FDA Adverse Event
Malfunction
Summary report: N
5MM MONOPOLAR HANDLE 33CM
MDR report key: 3933570
·
Received July 15, 2014
Report
- Report Number
- 0002936485-2014-00503
- Event Type
- Malfunction
- Date Received
- July 15, 2014
- Date of Event
- June 22, 2014
- Report Date
- June 22, 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. VISUAL INSPECTION SHOWED DENTS AND SCRATCHES ON THE SHAFT'S INSULATION. FUNCTIONAL INSPECTION : THE HANDLE WAS TESTED WITH AN INSULSCAN AND FAILED. PROBABLE ROOT CAUSES COULD BE USER MISUSE, USER EXCESSIVE FORCE, IMPROPER CLEANING AND STERILIZATION, 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 |
|---|---|---|---|---|---|---|---|
| 414371 | 5MM MONOPOLAR HANDLE 33CM | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 06222014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |