FDA Adverse Event
Malfunction
Summary report: N
5MM, 45CM PEEK MONOPOLAR HANDLE
MDR report key: 6045830
·
Received October 20, 2016
Report
- Report Number
- 0002936485-2016-00993
- Event Type
- Malfunction
- Date Received
- October 20, 2016
- Date of Event
- August 15, 2016
- Report Date
- March 20, 2017
- Manufacturer
- STRYKER ENDOSCOPY-SAN JOSE
- Product Code
- OCZ
- PMA / PMN Number
- K973259
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).
Additional Manufacturer Narrative · 1
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 PRODUCT WAS RETURNED FOR INVESTIGATION AND THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION WAS DAMAGED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULATION WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 697100 | 5MM, 45CM PEEK MONOPOLAR HANDLE | ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED | OCZ | STRYKER ENDOSCOPY-SAN JOSE | 1442304H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |