FDA Adverse Event
Malfunction
Summary report: N
5MM, 45CM PEEK MONOPOLAR HANDLE
MDR report key: 3974245
·
Received August 1, 2014
Report
- Report Number
- 0002936485-2014-00568
- Event Type
- Malfunction
- Date Received
- August 1, 2014
- Date of Event
- July 9, 2014
- Report Date
- July 9, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- KOG
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 SMALL DENTS AND SCRATCHES WERE PRESENT. THE HANDLE FAILED INSULATION INTEGRITY TEST NEAR THE DISTAL END. THE PROBABLE ROOT CAUSES COULD BE HANDLING DURING PROCESSING/CLEANING, 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 |
|---|---|---|---|---|---|---|---|
| 450038 | 5MM, 45CM PEEK MONOPOLAR HANDLE | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 1245799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |