FDA Adverse Event
Malfunction
Summary report: N
5MM, 33CM PEEK MONOPOLAR HANDLE 33CM
MDR report key: 6045371
·
Received October 20, 2016
Report
- Report Number
- 0002936485-2016-00988
- Event Type
- Malfunction
- Date Received
- October 20, 2016
- Date of Event
- September 26, 2016
- Report Date
- March 14, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OCZ
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. HOWEVER, SHOULD IT BECOME AVAILABLE IT WILL BE PROVIDED IN FUTURE REPORTS. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
(B)(4). ALLEGED FAILURE: DIDN'T PASS INSULATION TEST. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE/S COULD BE NORMAL WEAR, USER MISUSE, AND IMPROPER STERILIZATION METHODS. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem · 1
IT WAS REPORTED THE INSULATION IS COMPROMISED.
Description of Event or Problem · 1
IT WAS REPORTED THE INSULATION IS COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697078 | 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | STRYKER ENDOSCOPY-SAN JOSE | 1441219¿H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |