FDA Adverse Event
Malfunction
Summary report: N
10MM, 33CM PEEK MONOPOLAR HANDLE
MDR report key: 3974090
·
Received August 1, 2014
Report
- Report Number
- 0002936485-2014-00555
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 7, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- KOG
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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. INSULATION IS CHIPPED OFF NEAR THE DISTAL END. THE PROBABLE ROOT CAUSES ARE USER MISUSE OR NORMAL WEAR. 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 |
|---|---|---|---|---|---|---|---|
| 451012 | 10MM, 33CM PEEK MONOPOLAR HANDLE | KOG. | KOG | STRYKER ENDOSCOPY-SAN JOSE | 1343724H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |