Catalog Number C2602 |
Device Problem
Output Problem (3005)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
|
|
Event Description
|
This is 2 of 3 reports linked to mfg report numbers: 3006697299-2021-00004, 3006697299-2021-00006.A facility reported that the cusa excel 36khz straight handpiece (c2602) failed during an unspecified surgery.There was no delay in surgery nor patient injury reported.Additional information has been requested.
|
|
Manufacturer Narrative
|
Cusa excel 36khz straight handpiece (c2602 ) was returned for evaluation: device history record (dhr): the dhr documentation was reviewed and no anomalies that could be associated with the complaint incident was observed.Failure analysis - the reported complaint was confirmed.The device did not meet specification during testing.The handpiece issue was due to the defected transducer.Technician replaced a new transducer and new housing assembly.The handpiece was retested and passed all test.Manufacturing, workmanship, or material deficiency identification statement.Root cause - transducer delamination was found to be the root cause.No adverse trend identified.
|
|
Search Alerts/Recalls
|