FDA Adverse Event
Injury
Summary report: N
HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST
MDR report key: 2133932
·
Received June 20, 2011
Report
- Report Number
- 3005075853-2011-02503
- Event Type
- Injury
- Date Received
- June 20, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 1, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K063192
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. ONLY YEAR KNOWN, ASSUMED (B)(6) THAT COMPLAINT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST-OP TO A THYROID PROCEDURE, REOPERATION WAS NECESSARY DUE TO BLEEDING. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC FOCUS* CURVED SHEARS, TORQUE WRENCH AND GRIP ASSIST | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |