FDA Adverse Event
Malfunction
Summary report: N
AL-III W/FOOT CONTROL
MDR report key: 3182619
·
Received June 21, 2013
Report
- Report Number
- 1045834-2013-02587
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- March 31, 2011
- Report Date
- March 31, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GEY
- PMA / PMN Number
- K970530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE INVESTIGATION IS STILL IN PROCESS. WHEN THE INVESTIGATION HAS BEEN COMPLETED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT.(B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "LEAKING OIL" AND THE HOSE WAS DAMAGED. THE DEVICE WAS NOT USED IN SURGERY. IT IS UNKNOWN IF INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 284073 | AL-III W/FOOT CONTROL | MOTOR, SURGICAL INSTRUMENT, AC-POWERED-FOOT CONTROL | GEY | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |