FDA Adverse Event
Malfunction
Summary report: N
5MM, 45CM PEEK MULTI-FUNCTION HANDLE
MDR report key: 6158097
·
Received December 9, 2016
Report
- Report Number
- 0002936485-2016-01154
- Event Type
- Malfunction
- Date Received
- December 9, 2016
- Date of Event
- November 14, 2016
- Report Date
- June 6, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OCZ
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE MANUFACTURE DATE IS NOT KNOWN. ALLEGED FAILURE: INSULATION CRACKED. PROBABLE ROOT CAUSE: POOR AUTOCLAVE RELIABILITY, INCORRECT STERILIZATION/REPROCESSING PROCEDURE, HANDLING PROCEDURES, CONTACT FORCES, PRODUCT USED BEYOND DEFINED USEFUL LIFE. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
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 IS CRACKED.
Description of Event or Problem · 1
IT WAS REPORTED THE INSULATION IS CRACKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 815133 | 5MM, 45CM PEEK MULTI-FUNCTION HANDLE | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | STRYKER ENDOSCOPY-SAN JOSE | ¿1447267H¿ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |