FDA Adverse Event
Malfunction
Summary report: N
PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT
MDR report key: 6142996
·
Received December 2, 2016
Report
- Report Number
- 0002936485-2016-01134
- Event Type
- Malfunction
- Date Received
- December 2, 2016
- Date of Event
- November 4, 2016
- Report Date
- June 15, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OCZ
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 FAILING. THE FAILURE(S) IDENTIFIED IN THE INVESTIGATION IS CONSISTENT WITH THE COMPLAINT RECORD. THE PROBABLE ROOT CAUSES CAN BE ATTRIBUTED TO IMPROPER CLEANING OR STERILIZATION, OR NORMAL WEAR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. MFG DATE: 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 |
|---|---|---|---|---|---|---|---|
| 793884 | PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | STRYKER ENDOSCOPY-SAN JOSE | ¿1140932D¿ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |