FDA Adverse Event
Malfunction
Summary report: N
ULTRASONIC DISSECTOR
MDR report key: 3102057
·
Received April 22, 2013
Report
- Report Number
- 1717344-2013-00290
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 16, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A CHOLECYSTECTOMY, THE DEVICE STOPPED WORKING. IT WAS DISCOVERED THAT A PIECE OF HE ACTIVE WAVEGUIDE HAD DISENGAGED INTO THE PT CAVITY. THE PT WAS IMMEDIATELY RETRIEVED. THE SURGEON INSTALLED A NEW DISSECTOR ONTO THE SYSTEM AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172058 | ULTRASONIC DISSECTOR | ULTRASONIC DISSECTION SYSTEM | LFL | COVIDIEN LP | 235694X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ULTRASONIC REUSABLE BATTERY PACK - SERIAL# UNK| ULTRASONIC REUSABLE GENERATOR - SERIAL# UNK |