Events

Rappel de Cystoscopy Bridges

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Olympus Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-01158-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-09-06
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01158-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer owi has received complaints about fragments of adhesive detaching from the inside of the working channel of cystoscopy bridges. chipping, cracking and delamination of the adhesive may occur when inserting an instrument through the working channel. in the rare occurrence that an adhesive fragment may fall in to the patient it can be flushed out with irrigation fluid or passed naturally. the retrieval of large adhesive fragments may require additional surgical treatment and extended anaesthesia. to date, there have been no reports of adverse events or patient injury related to this issue worldwide.
  • Action
    1. Users with affected lots should continue to use existing Cystoscopy Bridges until replacements are obtained. 2. Complete and return the supplied reply form to Olympus. 3. Check the delivery details and number of affected devices listed in the customer letter that need replacing from Olympus, and contact them on 1300 657 699 with any changes. 4. Upon receipt of the replacement Cystoscopy Bridges from Olympus dispose the affected bridges and use the replacement devices. 5. Users who have distributed or transferred any of the affected products to other facilities should forward this recall notice and please notify Olympus so that they can follow up with that facility directly.

Device

Cystoscopy Bridges
  • Modèle / numéro de série
    Cystoscopy BridgesBridge, one wayModel Number: A20976ALot Numbers: 14XW, 152W, 153W, 154W, 156W, 158W, 15YW, 164W, 165W, 169W, 16XW, 172WBridge, two wayModel Number: A20977ALot Numbers: 148W, 149W, 14XW, 14YW, 14ZW, 154W, 155W, 156W, 159W, 15XW, 163W, 166W, 169W, 171WARTG Number: 146365
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd