FDA Adverse Event
Malfunction
Summary report: N
PKG, 5MM PEEK MONOPOLAR HANDLE
MDR report key: 6142185
·
Received December 2, 2016
Report
- Report Number
- 0002936485-2016-01126
- Event Type
- Malfunction
- Date Received
- December 2, 2016
- Date of Event
- November 7, 2016
- Report Date
- April 11, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OCZ
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. ALLEGED FAILURE: INSULATION FAILED THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSE/S COULD BE NORMAL WEAR, STERILIZATION METHODS, AND USER MISUSE. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MANUFACTURE DATE IS NOT KNOWN. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE MANUFACTURE DATE IS NOT KNOWN AT THIS TIME. ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THE INSULATION FAILED.
Description of Event or Problem · 1
IT WAS REPORTED THE INSULATION FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 794093 | PKG, 5MM PEEK MONOPOLAR HANDLE | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | STRYKER ENDOSCOPY-SAN JOSE | 0641957D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |