FDA Adverse Event
Malfunction
Summary report: N
5MM PEEK MULTIFUNCTION HANDLE
MDR report key: 6158441
·
Received December 9, 2016
Report
- Report Number
- 0002936485-2016-01151
- Event Type
- Malfunction
- Date Received
- December 9, 2016
- Date of Event
- November 14, 2016
- Report Date
- May 5, 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). ALLEGED FAILURE: INSTRUMEDICTS EIB JAYLEN HARRIS SHAFT INSULATION CRACKED, COMPROMISED, BROKE, OR BREACHED (FAILED INSULSCAN) . THE FAILURE ALLEGED IN THE COMPLAINT RECORD WAS NOT CONFIRMED/DUPLICATED DURING THE PRODUCT INVESTIGATION. THE PROBABLE ROOT CAUSE/S COULD BE USER MISUSE. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Additional Manufacturer Narrative · 1
(B)(4). 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 |
|---|---|---|---|---|---|---|---|
| 815260 | 5MM PEEK MULTIFUNCTION HANDLE | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | STRYKER ENDOSCOPY-SAN JOSE | 1544277K¿ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |