FDA Adverse Event
Malfunction
Summary report: N
5MM, 33CM PEEK MONOPOLAR HANDLE 33CM
MDR report key: 3974424
·
Received August 1, 2014
Report
- Report Number
- 0002936485-2014-00553
- 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
- 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 FOR INSULATION BUT NOT THE HANDLE. DENTS AND SCRATCHES WERE SEEN ON THE INSULATION. THE INSULATION WAS TESTED FOR CRACKED/DAMAGES. THE INSULATION PASSED THE INSULATION INTEGRITY TEST. THE PROBABLE ROOT CAUSES ARE USER MISUSE, USER ERROR, IMPROPER STERILIZATION METHODS, OR NORMAL WEAR.
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 |
|---|---|---|---|---|---|---|---|
| 450406 | 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 07092014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |