FDA Adverse Event
Malfunction
Summary report: N
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
MDR report key: 1130387
·
Received August 20, 2008
Report
- Report Number
- 3005075853-2008-01313
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- August 5, 2008
- Report Date
- August 6, 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
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THYROID PROCEDURE, THE DEVICES HAD PIECE'S OF TISSUE PAD FLAKE OFF AND FALL INTO THE PATIENT. THE PIECES WERE RETRIEVED WITH FORCEPS. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE.
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 |