Model Number CAT01549 |
Device Problems
Break (1069); Material Integrity Problem (2978)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/15/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
|
|
Event Description
|
It was reported that the tip of the device broke during the procedure.The tip was retrieved.
|
|
Manufacturer Narrative
|
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: tip break.Probable root cause: design: inadequate material selection to support movement/manipulation by user cannula tubing thickness too small to support movement/manipulation by user cannula size or geometry does not promote proper visualization of joint excessively sharp tip of cannula damages tissue manufacturing cannula not assembled, molded or machined to specification application excessive force poor visualization through arthroscope.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.
|
|
Event Description
|
It was reported that the tip of the device broke during the procedure.The tip was retrieved.
|
|
Search Alerts/Recalls
|