FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATE
MDR report key: 3905252
·
Received May 28, 2014
Report
- Report Number
- 2951238-2014-00233
- Event Type
- Malfunction
- Date Received
- May 28, 2014
- Date of Event
- April 30, 2014
- Report Date
- May 8, 2014
- Manufacturer
- OLYMPUS MED SYSTEM CORP
- Product Code
- GEI
- PMA / PMN Number
- K111202
- Removal / Correction Number
- Z-0342-2014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HANDPIECE WAS RETURNED TO OLYMPUS FOR EVAL. THE EVAL CONFIRMED THE PROBE DAMAGE ERROR (U509) WAS DUE TO A FRACTURE NOTED ON THE PROXIMAL END OF THE PROBE. THE TEFLON PAD SHOWED NORMAL WEAR. A REPLACEMENT DEVICE WAS SENT TO THE USER FACILITY.
Description of Event or Problem · 1
OLYMPUS WAS INFORMED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE PROBE TIP ON THE HANDPIECE BROKE OFF. A SECOND HANDPIECE WAS UTILIZED AND REPORTEDLY STOPPED WORKING AFTER DISPLAYING NUMEROUS ERROR CODES. THE PROCEDURE WAS COMPLETED. THERE WAS NO PT INJURY REPORTED. OLYMPUS F/U WITH THE USER FACILITY TO OBTAIN ADD'L INFO BUT WITH NO RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314897 | OLYMPUS THUNDERBEAT 5 MM, 35 CM, FRONT ACTUATE | ULTRASONIC SURGICAL DEVICE | GEI | OLYMPUS MED SYSTEM CORP | TB-0535FC | K4218 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TB-0535FC (MDR# 2951238-2014-00232) |