FDA Adverse Event
Malfunction
Summary report: N
AUTOLUBE III
MDR report key: 4181826
·
Received October 17, 2014
Report
- Report Number
- 1045834-2014-14508
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Report Date
- April 16, 2013
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- GEY
- PMA / PMN Number
- PK970530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DURING PRE-REPAIR ASSESSMENT PERFORMED BY A TECHNICIAN, FUNCTIONAL TESTING WAS PERFORMED AND REVEALED A HIGH PRESSURE LEAK. THIS WAS ATTRIBUTED TO NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
DEVICE WAS RETURNED FOR AN UNKNOWN REASON. DURING THE SERVICE TECHNICIAN FOUND THAT THE DEVICE WAS LEAKING. THIS IS REPORT 1 OF 1 FOR COMPLAINT# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 661638 | AUTOLUBE III | MOTOR, SURGICAL INSTRUMENT, AC-POWERED | GEY | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |