FDA Adverse Event
Malfunction
Summary report: N
SURGILAV PLUS HANDPIECE SET
MDR report key: 4192542
·
Received October 22, 2014
Report
- Report Number
- 0001811755-2014-03707
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 22, 2014
- Report Date
- September 24, 2014
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- FQH
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER DISCARDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SURGILAV PLUS HANDPIECE SET WAS BEING USED IN A PROCEDURE WHEN IT SEPARATED AT THE JOINT DURING KNEE SUCTION. IT WAS CONFIRMED THAT NO PIECES OF THE DEVICE FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT OR USER INJURIES, AND NO ADVERSE CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 671674 | SURGILAV PLUS HANDPIECE SET | LAVAGE, JET | FQH | STRYKER INSTRUMENTS-KALAMAZOO | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |