Events

Alerte De Sécurité sur Sciatic Nerve Retractors

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Synthes GmbH.

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
  • Date
    2018-04-04
  • Date de publication de l'événement
    2018-04-04
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180404.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: synthes gmbh sciatic nerve retractors medical device manufacturer, synthes gmbh, has issued a medical device safety alert concerning its sciatic nerve retractors. the affected devices are identified as the following:- retractor f/sciatic nerve [part numbers: 03.100.013; lot numbers: t104992, t114599, t140390, t140674, t140675, t140676, t140677, t141539, t143644, t144855, t145296, t145589, t145819, t146660, t147930, t148624, t149725, t149726, t151370, t152806, t152807, t153692, t155648, t156708, t160394, t939640, t987813] retractor f/sciatic nerve long [part number: 03.100.014; lot numbers: t104993, t108115, t114598, t140566, t140665, t140670, t140671, t140673, t141540, t143687, t144854, t145585, t145590, t145932, t146657, t147929, t148552, t148553, t149727, t149728 t151369, t151488, t152808, t152809, t153884, t155649, t958061] the manufacturer is initiating a product removal of the above part and lot numbers of sciatic nerve retractors. these devices are part of the 3.5mm low profile pelvic system and intended for drawing back soft tissue during orthopaedic surgery. according to the manufacturer, there is the potential for micropores to form on the hollow handle of the sciatic nerve retractor. as the pores may increase in size, it is possible that fluids may enter the hollow handle during surgery. thus, even with diligent reprocessing/sterilization of the retractor, subsequent patients may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use. additionally, if the discoloration and/or moisture are not identified within the packaging of the affected sciatic nerve retractors preoperatively, there is a potential for surgical delay due to the time required to investigate and decide next steps. the users are requested to immediately review their inventory to identify and quarantine the affected products. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 april 2018.

Device

Sciatic Nerve Retractors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Synthes GmbH Sciatic Nerve Retractors
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH