FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC ACE
MDR report key: 2151879
·
Received July 6, 2011
Report
- Report Number
- 3005075853-2011-02258
- Event Type
- Malfunction
- Date Received
- July 6, 2011
- Report Date
- May 23, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LFL
- PMA / PMN Number
- K042777
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.
Additional Manufacturer Narrative · 1
(B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LIVER RESECTION PROCEDURE THE END OF THE DEVICE WAS GETTING WARM AND THEN THE END FELLL OFF. UNKNOWN HOW THE CASE WAS COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC ACE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | G9L10L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |