FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T
MDR report key: 3915287
·
Received May 27, 2014
Report
- Report Number
- 8031000-2014-00249
- Event Type
- Malfunction
- Date Received
- May 27, 2014
- Date of Event
- April 18, 2014
- Report Date
- May 6, 2014
- Manufacturer
- ZIMMER SURGICAL S.A
- Product Code
- HAB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE TRIGGER HANDPIECE WAS VERY NOISY AND THE MOTOR STUTTERS. IN ADDITION, THE TRIGGER FUNCTION IS DISABLED, ONCE THE HANDPIECE MOTOR IS STARTED IT WILL NOT SHUT DOWN BY RELEASING THE TRIGGER. THERE WAS NO PATIENT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311669 | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T | UNIVERSAL MODULAR ELECTRIC/BATTERY DOUBLE T | HAB | ZIMMER SURGICAL S.A | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |