FDA Adverse Event
Malfunction
Summary report: N
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
MDR report key: 1190754
·
Received October 7, 2008
Report
- Report Number
- 3005075853-2008-02154
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 25, 2008
- Report Date
- October 2, 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
- TX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE DEVICE WHITE TISSUE PAD WAS FLAKING OFF OF THE DEVICE AS THEY USED IT. THEY BURNED IN THE PAD AND CONTINUED ON WITH THE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
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 | GENERATOR| HANDPIECE |