FDA Adverse Event
Malfunction
Summary report: N
HARMONIC FOCUS CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
MDR report key: 1082914
·
Received July 25, 2008
Report
- Report Number
- 3005075853-2008-00673
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 30, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 07/25/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE, THE TIP OF THE DEVICE HAD LITTLE OR NO TISSUE EFFECT WHEN PLACED ON TISSUE ON THE MAX APPLICATION. IT WOULD COAGULATE VERY SLOWLY UNLESS IT WAS ON MIN. THEY USED THE DEVICE TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE 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 |