FDA Adverse Event
Malfunction
Summary report: N
10MM, 33CM PEEK MONOPOLAR HANDLE
MDR report key: 3951512
·
Received July 23, 2014
Report
- Report Number
- 0002936485-2014-00518
- Event Type
- Malfunction
- Date Received
- July 23, 2014
- Date of Event
- June 30, 2014
- Report Date
- June 30, 2014
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- KOG
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. A CRACK WAS SEEN ON THE INSULATION NEAR THE DISTAL TIP. THE INSULATION WAS TESTED FOR CRACKED/DAMAGES. THE INSULATION FAILED THE INSUL SCAN TEST. THE PROBABLE ROOT CAUSES ARE USER MISUSE, IMPROPER STERILIZATION METHODS, OR 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 |
|---|---|---|---|---|---|---|---|
| 431652 | 10MM, 33CM PEEK MONOPOLAR HANDLE | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 1144345D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |