Events

Alerte De Sécurité sur cystoscopy bridges and working inserts

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

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
    2017-08-08
  • Date de publication de l'événement
    2017-08-08
  • 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_20170808.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: olympus cystoscopy bridges and working inserts medical device manufacturer, olympus, has issued a medical device safety alert concerning its cystoscopy bridges and working inserts. the affected devices are identified as follows:- model description: 1) working insert, with ramp, one way; 2) bridge, one way; 3) bridge, two way model numbers: 1) a20975a; 2) a20976a; 3)a20977a lot numbers: 1) n/a; 2) 152w, 154w, 157w, 16yw; 3) 151w, 152w, 153w the manufacturer has received complaints about fragments of adhesive which detached from inside the working channel of the referenced cystoscopy bridge models. cracking, chipping, missing pieces, and delamination of the adhesive have been observed. investigations have confirmed that this adhesive can detach during the intended use of the cystoscopy bridge or working insert, e.G. when inserting an instrument through the working channel. as a result, a fragment of the adhesive may fall inside the patient’s bladder or urethra and will need to be retrieved. although typically flushed out with irrigation fluid or passed naturally, the retrieval of large fragments of the adhesive could require additional surgical treatment. furthermore, the procedure can be prolonged resulting in extended anaesthesia. according to the manufacturer, there has been no report about an adverse event or patient injury related to this issue. the manufacturer will replace the devices completely. investigation results confirmed that these devices are safe to use until being replaced. users are advised to take the following actions:- inspect the inventory for the referenced devices and identify any of the specified model and lot numbers identified above. contact the manufacturer to schedule the successive return of all the affected devices for replacement and to arrange for temporary loan units if applicable. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 august 2017.

Device

cystoscopy bridges and working inserts
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Olympus Cystoscopy Bridges and Working Inserts
  • Manufacturer
    Olympus

Manufacturer

Olympus