Events

Alerte De Sécurité sur Trade name: Surgical Focus Vol. ANVISA registration number: 80259110094. Model affected: Focus Volista 600 SF. . Trade name: Surgical Powerled / HLED. ANVISA registration number: 80259110085. Model affected: Powerled / HLED 700 SF. . Technical name: Surgical Focus. Hazard class: I. Serial number affected: 103082; 103507; 103782; 103787; 103793; 103975; 104298; 104300; 110041; 1116H000576356; 1214H000214210; 1214H000214211; 1214H000214212; 1214H000214213; 1216H000580491; 1413H000110894; 1413H000110895; 1413H000110896; 1416H000587798; 1514H000222395; 2813H000135240; 2813H00013542; 2914H000253328; 2914H000253340; 2914H000253342; 2914H000253343; 2914H000253344; 2914H000253345; 2914H000253346; 2914H000253347; 3014H000253651; 3014H000253652; 3014H000253653; 3014H000253654; 3014H000253662; 3014H000253663; 3014H000253664; 3114H000255770; 3114H000255771; 3114H000255772; 3214H000259657; 3914H000275962; 3914H000275963; 3914H000275964; 3914H000275965; 3914H000275966; 3914H00027Z967; 4114H000280550; 4114H000280551; 4114H000280552; 4114H000280553; 4114H000280556; 413H000089296; 4214H000283137; 4313H000164912; 4613H000171745; 4613H000171746; 4613H000171747; 4615H000509755; 4615H000509756; 4615H000509757; 4615H000509758; 4615H000509759; 4615H000509760; 4615H000509761; 4615H000512610; 4615H000512624; 4615H000512625; 4615H000512626; 4615H000512628; 4713H000173854; 4713H000173867; 4713H000173868; 4813H000176068; 4813H000176069; 4814H000300084; 4814H000300085; 4814H000300086; 4814H000300087; 4814H000300088; 4814H000300089; 4814H000300090; 4814H000300091; 500054; 614H000200318; 614H000200319; 713H000095410; 713H000095411; 713H000095412; ON012831; ON013619; ON013620; ON015617; ON015620; ON015628; ON016647; ON016763; ON018083; ON018084; ON018849; ON019215; ON019217; ON019218; ON019219; ON019220; ON019515; ON019996; ON019997; ON019998; ON019999; ON020000; ON020001; ON020003; ON020198; ON020199; ON020275; ON020276; ON020285; ON020286; ON021262; ON021263; ON021618; ON021638; ON021666; ON022360; ON022361; ON022362; ON022363; ON022364; ON022365; ON023111; ON023113; ON023114; ON023116; ON101177; ON101228; ON102140; ON102141; ON102203; ON102204; ON102205; ON102206; ON102207; ON102208; ON102209; ON102210; ON102211; ON102212; ON102213; ON102214; ON102215; ON102216; ON102217; ON102329; ON102330; ON102331; ON102363; ON102425; ON102427; ON102428; ON102582; ON102976; ON102977; ON102978; ON102979; ON102981; ON102984; ON102985; ON102986; ON102987; ON102988; ON102989; ON102990; ON102991; ON102992; ON102993; ON103078; ON103084; ON103099; ON103100; ON103202; ON103203; ON103218; ON103230; ON103240; ON103242; ON103243

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Maquet do Brasil Equipamentos Medicos LTDA; Maquet SAS..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2525
  • Date
    2018-03-19
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    This MAQUET POWERLED / HLED and VOLISTA Field Notification needs to be distributed to those individuals who need to be aware within their organization - or any organization to which the potentially affected devices have been transferred. Maintain awareness of this notification and the resulting action for the appropriate period of use of the device to ensure the effectiveness of corrective action. In cases where you as a customer choose not to comply with the corrective action requirements described above, MAQUET can not accept any responsibility for problems related to safety or legal liabilities caused by the failure to respond to the Field Corrective Notices. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link - Date of identification of the problem by the company: 12/20/2017 - Date of notification notice to Anvisa: 01/17/2018 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    Maquet received complaints regarding unintended dome fluctuation during surgery due to premature wear of the brake bolts. the observed movement is a slow rotation of the dome around the axis (see image below), potentially diverting the light field from the wound. this potential malfunction is caused by the brake bolts which have worn prematurely because the center of gravity of the dome is not precisely aligned with the single fork articulated arm. this is due to component tolerances and limits of manufacturing capabilities. we do not see the problem as any potential hazard, but we want to avoid the recurrence of any event related to our customers. the current action is to modernize existing articulated arms with new bolts with improved brake performance. devices involved for your market are limited to those listed in the consignee list.
  • Action
    Field Action Code MSA2017005IU triggered under the responsibility of Maquet do Brasil Equipamentos Medicos LTDA. Will make correction in the field.

Device

Trade name: Surgical Focus Vol. ANVISA registration number: 80259110094. Model affected: Focus Vo...

Manufacturer

Maquet do Brasil Equipamentos Medicos LTDA; Maquet SAS.
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    ANVSANVISA