Events

Recall of Cystoscopy Bridges

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Olympus Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01158-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01158-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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