Events

Field Safety Notices about cystoscopy bridge

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by OLYMPUS KEYMED.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-09-01
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Olympus is implementing a field safety corrective action ("fsca") of the cystoscopy bridges and the working insert referenced above. cystoscopy bridges and working inserts are used for endoscopic diagnosis and treatment in urologic applications. olympus has initiated this fsca after receiving 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 anesthesia. .

Device

cystoscopy bridge
  • Model / Serial
    A20975A Working insert, with ramp, one way 13ZW, 149W, 14ZW, 159W, 15ZW, 162W, 168W A20976A Bridge, one way 146W, 147W, 148W, 149W, 14XW, 14YW, 14ZW, 151W, 152W, 153W, 154W, 155W, 156W, 157W, 158W, 159W, 15XW, 15YW, 161W, 162W, 163W, 164W, 165W, 167W, 168W, 16YW, 16ZW, 171W, 172W A20977A Bridge, two way 146W, 148W, 149W, 14XW, 14ZW, 151W, 152W, 153W, 154W, 155W, 156W, 158W, 159W, 15XW, 15YW, 161W, 162W, 163W, 164W, 165W, 166W, 167W, 168W, 169W, 16XW, 16ZW, 171W, 172W, 173W
  • Manufacturer
    OLYMPUS KEYMED

Manufacturer

OLYMPUS KEYMED