FDA Adverse Event
Malfunction
Summary report: N
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
MDR report key: 1122042
·
Received August 14, 2008
Report
- Report Number
- 3005075853-2008-01228
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- July 24, 2008
- Report Date
- August 1, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- LFL
- PMA / PMN Number
- K063192
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE DEVICE'S BLADE CRACKED AND DROPPED OFF. THEY RETRIEVED THE BLADE FROM THE PT. THE CASE WAS COMPLETED CONVERTING TO TRADITIONAL CCT METHOD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST | LFL | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |