FDA Adverse Event
Malfunction
Summary report: N
5MM MONOPOLAR HANDLE 33CM
MDR report key: 3924498
·
Received July 10, 2014
Report
- Report Number
- 0002936485-2014-00461
- Event Type
- Malfunction
- Date Received
- July 10, 2014
- Date of Event
- June 17, 2014
- Report Date
- June 17, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- KOG
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED. THE MONOPOLAR HANDLE WAS VISUALLY INSPECTED FOR DAMAGES, AND A SCRATCH WAS SEEN NEAR THE DISTAL END. THE HANDLE FAILED INSULSCAN TEST NEAR THE DISTAL END OF THE SHAFT. PROBABLE ROOT CAUSES COULD BE DUE TO USER MISUSE, OR HANDLING DURING CLEANING/REPROCESSING, OR NORMAL WEAR AND TEAR. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION HAS BEEN COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405246 | 5MM MONOPOLAR HANDLE 33CM | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 0647015D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |