OLYMPUS WINTER & IBE GMBH TELESCOPE, 10 MM, 30°, HD, QUICK LOCK, AUTOCLAVABLE; THORACOSCOPE SYSTEM
|
Back to Search Results |
|
Model Number WA53005A |
Device Problem
Loose or Intermittent Connection (1371)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/21/2023 |
Event Type
malfunction
|
Event Description
|
The customer reported that the light guide connector was loose on a telescope, 10 mm, 30°, hd, quick lock, autoclavable.The event occurred during reprocessing.The procedure was completed with a similar device.There was no procedural delay, or no patient harm associated with the event.
|
|
Manufacturer Narrative
|
The device was returned and evaluated, and the customer¿s allegation (loose light guide connector) was confirmed.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
|
|
Manufacturer Narrative
|
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the event occurred due to use of excessive force by the customer.Olympus will continue to monitor field performance for this device.
|
|
Search Alerts/Recalls
|
|
|