FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 6 PRECISION HANDPIECE
MDR report key: 2241574
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03280
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 15, 2011
- Report Date
- August 16, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- KIJ
- PMA / PMN Number
- K972367
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE HAS NOT YET BEEN RECEIVED AT THE MFR FOR TESTING. AN EVAL WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE HANDPIECE WAS RETURNED TO THE IN-COUNTRY SERVICE CENTER, AND DURING THE INSPECTION A CLEAR OILY RESIDUE WAS FOUND ON THE DEVICE. THERE WAS NO PT INVOLVEMENT DURING THIS EVENT. THERE WAS NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 6 PRECISION HANDPIECE | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |