FDA Adverse Event
Malfunction
Summary report: N
SYS 6 RECIP
MDR report key: 1854433
·
Received September 30, 2010
Report
- Report Number
- 1811755-2010-01289
- Event Type
- Malfunction
- Date Received
- September 30, 2010
- Date of Event
- September 3, 2010
- Report Date
- September 3, 2010
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER AND A SAMPLE WAS TAKEN FOR FURTHER ANALYSIS. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE WAS LEAKING OIL OUT OF THE BOTTOM. THE CUSTOMER CLEANED, STERILIZED AND USED THE HANDPIECE FOR THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYS 6 RECIP | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |