FDA Adverse Event
Malfunction
Summary report: N
ULTRASONIC DISSECTOR QTY OF 6
MDR report key: 3173582
·
Received June 10, 2013
Report
- Report Number
- 1717344-2013-00413
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Date of Event
- May 1, 2013
- Report Date
- June 6, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 LAPAROTOMY, THE DEVICE STOPPED WORKING. THE SURGEON REMOVED THE DEVICE FROM THE PT AND THEN THE ACTIVE WAVEGUIDE DISENGAGED FROM THE DEVICE. NO ADDITIONAL DETAILS WERE MADE AVAILABLE FROM THE SITE CONTACT. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261422 | ULTRASONIC DISSECTOR QTY OF 6 | ULTRASONIC DISSECTOR | LFL | COVIDIEN LP | 249942X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ULTRASONIC REUSABLE BATTER PACK: SERIAL # UNKNOWN| ULTRASONIC REUSABLE GENERATOR: SERIAL # UNKNOWN |