FDA Adverse Event
Malfunction
Summary report: N
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
MDR report key: 1203790
·
Received October 10, 2008
Report
- Report Number
- 3005075853-2008-02275
- Event Type
- Malfunction
- Date Received
- October 10, 2008
- Date of Event
- September 15, 2008
- Report Date
- September 19, 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
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A NECK DISSECTION PROCEDURE, THE DEVICE GOT EXTREMELY HOT AND FAULTED INTO ERROR CODE 5. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR 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 | E4LA6N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR| HANDPIECE |