FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE
MDR report key: 3894480
·
Received April 25, 2014
Report
- Report Number
- 8031000-2014-00224
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- March 21, 2014
- Report Date
- April 1, 2014
- Manufacturer
- ZIMMER SURGICAL S.A.
- Product Code
- HAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THA THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE MOTOR STUTTERED AND BLOCKED AFTER A FEW SECONDS UNDER TENSION. THERE WAS NO PATIENT HARM; HOWEVER THERE WAS A DELAY IN SURGERY FOR APPROXIMATELY 30 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252548 | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE | HAB | ZIMMER SURGICAL S.A. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |