FDA Adverse Event
Malfunction
Summary report: N
ULTRACISION HARMONIC ACE
MDR report key: 2133519
·
Received June 20, 2011
Report
- Report Number
- 3005075853-2011-02479
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- May 20, 2011
- Report Date
- May 25, 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
- SN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME
Additional Manufacturer Narrative · 1
(B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN ENDOSCOPIC THYROIDECTOMY PROCEDURE, THERE WAS A SOLID TONE HEARD ON THE GENERATOR. THERE WAS NO ERROR MESSAGE DISPLAYED ON THE HARMONIC GENERATOR. HOWEVER WHEN THE INSTRUMENT WAS BEING CLEANED BY THE SCRUB NURSE, THE ACTIVE BLADE BROKE OUTSIDE THE PATIENT WHILE CLEANING THE DEVICE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ULTRACISION HARMONIC ACE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |