FDA Adverse Event
Malfunction
Summary report: N
SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP
MDR report key: 2941977
·
Received December 21, 2012
Report
- Report Number
- 2648666-2012-00386
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- November 20, 2012
- Report Date
- November 21, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- FQH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP AND THE BASE OF THE HANDLE FRACTURED DURING USE. A BACK-UP SET WAS USED TO COMPLETE THE PROCEDURE WITH NO PT OR USER INJURIES, AND THERE WERE NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SURGILAV PLUS HANDPIECE SET WITH MULTI-ORIFICE TIP | FQH | STRYKER INSTRUMENTS KALAMAZOO | 12158012 OR 12237012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |