FDA Adverse Event
Malfunction
Summary report: N
10MM, 33CM PEEK MULTI-FUNCTION HANDLE
MDR report key: 4252355
·
Received November 14, 2014
Report
- Report Number
- 0002936485-2014-00925
- Event Type
- Malfunction
- Date Received
- November 14, 2014
- Date of Event
- October 23, 2014
- Report Date
- October 23, 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. DURING INSPECTION OF THE 10MM, 33CM PEEK MULTI-FUNCTION HANDLE, DINGS AND SCRATCHES WERE NOTICED THROUGHOUT THE SHAFT. ALSO, A DEEP SCRATCH WAS NOTICED AT THE DISTAL TIP OF THE SHAFT. THE 10MM, 33CM PEEK MULTI-FUNCTION HANDLE FAILED THE INSULATION INTEGRITY TEST. THE PROBABLE ROOT CAUSE/S COULD BE NORMAL WEAR, USER MISHANDLING OR IMPROPER STERILIZATION. 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 |
|---|---|---|---|---|---|---|---|
| 736962 | 10MM, 33CM PEEK MULTI-FUNCTION HANDLE | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 0942246D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |