FDA Adverse Event
Malfunction
Summary report: N
MICRO OSCILLATING SAW
MDR report key: 2102369
·
Received May 19, 2011
Report
- Report Number
- 1811755-2011-01847
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 22, 2011
- Report Date
- April 26, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K032303
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE SVC TECH TOOK A SAMPLE OF THE SUBSTANCE FROM THE DEVICE AND IT WAS SENT OUT FOR TESTING. AN INVESTIGATION IS ANTICIPATED. THIS REPORT WILL BE UPDATED IF THE INVESTIGATION REQUIRES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PRODUCT WAS LEAKING OIL DURING A FOOT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICRO OSCILLATING SAW | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |