FDA Adverse Event
Malfunction
Summary report: N
5MM, 33CM PEEK MONOPOLAR HANDLE 33CM
MDR report key: 3083667
·
Received April 29, 2013
Report
- Report Number
- 0002936485-2013-00184
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- April 8, 2013
- Report Date
- April 8, 2013
- 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 FOR INVESTIGATION. THE REPORTED FAILURE MODE WAS CONFIRMED. DENTS AND SCRATCHES WERE SEEN ON THE INSULATION. THE INSULATION WAS TESTED FOR CRACKS/DAMAGES, THE INSULATION FAILED THE INSULATION SCAN TEST. THE PROBABLE ROOT CAUSES ARE USER MISUSE, IMPROPER STERILIZATION METHODS, AND/OR NORMAL WEAR. IN SUM, 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 THAT THE INSULATION OF THE DEVICE WAS COMPROMISED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION OF THE DEVICE WAS COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183656 | 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 1243590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |