FDA Adverse Event
Malfunction
Summary report: N
5MM, 33CM PEEK MONOPOLAR HANDLE 33CM
MDR report key: 3974077
·
Received August 1, 2014
Report
- Report Number
- 0002936485-2014-00552
- 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 FAILED THE INSULATION INTEGRITY TEST. THE PROBABLE ROOT CAUSES ARE USER MISUSE, IMPROPER STERILIZATION METHODS, NORMAL WEAR, OR USER ERROR. IN SUM, THE PRODUCT WAS RETURNED AND THE FAILURE MODE WAS CONFIRMED FOR INSULATION, BUT NOT THE HANDLE.
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 |
|---|---|---|---|---|---|---|---|
| 450769 | 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 1242403D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |