FDA Adverse Event
Malfunction
Summary report: N
ULTRASONIC DISSECTOR QTY OF 6
MDR report key: 3060630
·
Received March 27, 2013
Report
- Report Number
- 1717344-2013-00232
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Date of Event
- March 21, 2013
- Report Date
- March 21, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE, A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED AND FELL INTO THE PT CAVITY. THE PIECE WAS RETRIEVED BY THE SURGICAL STAFF. THE SURGEON USED ANOTHER TYPE OF DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 124817 | ULTRASONIC DISSECTOR QTY OF 6 | ULTRASONIC DISSECTION SYSTEM | LFL | COVIDIEN LP | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ULTRASONIC REUSABLE BATTERY PACK: SN # UNK| ULTRASONIC REUSABLE GENERATOR: SN # UNK |