FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 6 ASEPTIC HOUSING ASSY
MDR report key: 1892524
·
Received November 2, 2010
Report
- Report Number
- 1811755-2010-01578
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- October 4, 2010
- Report Date
- October 6, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, SO THE DEVICE HISTORY RECORD CANNOT BE REVIEWED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY HOUSING OPENED DURING A PROCEDURE. THERE WERE NO REPORTS OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED DESPITE NUMEROUS ATTEMPTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 6 ASEPTIC HOUSING ASSY | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |