FDA Adverse Event
Malfunction
Summary report: N
5MM, 45CM PEEK MULTI-FUNCTION HANDLE
MDR report key: 3974233
·
Received August 1, 2014
Report
- Report Number
- 0002936485-2014-00565
- 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. THE HANDLE WAS VISUALLY INSPECTED FOR DAMAGES, AND THE INSULATION HAS SCRATCHES NEAR THE DISTAL END. THE RATCHETING MECHANISM WAS LOCKED. WHEN UNLOCKED THE RATCHETING MECHANISM FUNCTIONED WITHOUT ISSUE. HOWEVER, THE HANDLE FAILED THE INSULSCAN TEST NEAR THE DISTAL END. PROBABLE ROOT CAUSES COULD BE USER MISUSE, OR HANDLING DURING CLEANING/REPROCESSING, OR NORMAL WEAR AND TEAR. 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 |
|---|---|---|---|---|---|---|---|
| 449754 | 5MM, 45CM PEEK MULTI-FUNCTION HANDLE | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 1245978H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |