FDA Adverse Event
Malfunction
Summary report: N
RECIP/STERNUM SAW
MDR report key: 2241636
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03218
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 12, 2011
- Report Date
- August 12, 2011
- 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 HANDPIECE WILL NOT BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION BASED ON THIS EVENT. A PRODUCT RETURN WAS REQUESTED, BUT THE ACCOUNT ADVISED THAT THE PRODUCT WILL NOT BE RETURNED. THE REPORTED CONDITION OF THE DEVICE LEAKING CANNOT BE CONFIRMED WITHOUT THE PRODUCT BEING AVAILABLE FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HANDPIECE BEGAN LEAKING A BLOOD-LIKE SUBSTANCE WHILE THE EQUIPMENT WAS BEING TESTED. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECIP/STERNUM SAW | KIJ | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |