FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36CM W ERG HANDLE
MDR report key: 1791204
·
Received August 2, 2010
Report
- Report Number
- 3005075853-2010-04403
- Event Type
- Malfunction
- Date Received
- August 2, 2010
- Date of Event
- July 8, 2010
- Report Date
- July 9, 2010
- 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
- KS
- Reporter Occupation
- OTHER
Narratives
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 THYROIDECTOMY PROCEDURE, A SURGEON USED THE DEVICE AS USUAL, BUT THE DEVICE DIDN'T WORK. HE CHANGED TO ANOTHER DEVICE, AND THEN THE DEVICE GAVE HIM FINE DISSECTION. THE DEVICE'S BLADE WAS BROKEN. SURGERY WAS PROLONGED FIVE MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36CM W ERG HANDLE | LFL INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | HANDPIECE| GENERATOR |