FDA Adverse Event
Malfunction
Summary report: N
5MM PEEK MULTIFUNCTION HANDLE
MDR report key: 4090633
·
Received September 15, 2014
Report
- Report Number
- 0002936485-2014-00720
- Event Type
- Malfunction
- Date Received
- September 15, 2014
- Date of Event
- August 25, 2014
- Report Date
- August 25, 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. DENTS AND SCRATCHES WERE SEEN ON THE INSULATION. ALSO SEPARATION ON THE INSULATION NEAR THE DISTAL END WAS NOTICED AND THE SHAFT IS BENT. STRYKER ETCHING FOR THE LOT#, PN, AND CE LABEL WERE NOT PRESENT. THIS IS AN INDICATION OF POSSIBLE THIRD PARTY REPAIR FOR THE INSULATION. 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 |
|---|---|---|---|---|---|---|---|
| 569688 | 5MM PEEK MULTIFUNCTION HANDLE | ENDOSCOPE AND/OR ACCESSORIES | KOG | STRYKER ENDOSCOPY-SAN JOSE | 08252014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |