FDA Adverse Event
Malfunction
Summary report: N
HARMONIC ACE 36CM W ERG HANDLE
MDR report key: 1901131
·
Received November 17, 2010
Report
- Report Number
- 3005075853-2010-06571
- Event Type
- Malfunction
- Date Received
- November 17, 2010
- Date of Event
- October 28, 2010
- Report Date
- October 29, 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
- TX, 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 BAND TO GASTRIC SLEEVE CONVERSION PROCEDURE, THE DEVICE'S BLADE BROKE OFF AND IT WAS RETRIEVED THROUGH THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HARMONIC ACE 36CM W ERG HANDLE | INSTRUMENT, ULTRASONIC SURGICAL | LFL | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GENERATOR AND HANDPIECE |