FDA Adverse Event
Malfunction
Summary report: N
5MM, 33CM PEEK MONOPOLAR HANDLE 33CM
MDR report key: 3854312
·
Received June 6, 2014
Report
- Report Number
- 0002936485-2014-00390
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 12, 2014
- Report Date
- May 12, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- KOG
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, 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 RECEIVED AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE DEVICE WAS DIAGNOSED FOR SCRATCHES ON INSULATION, WHICH CONFIRMS THE ALLEGED FAILURE MODE OF INSULATION DAMAGE. PROBABLE ROOT CAUSE: USER MISUSE, IMPROPER STERILIZATION METHODS, OR NORMAL WEAR. IN SUM, THE PRODUCT WAS RECEIVED AND THE REPORTED 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 |
|---|---|---|---|---|---|---|---|
| 332991 | 5MM, 33CM PEEK MONOPOLAR HANDLE 33CM | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 1142231D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |