FDA Adverse Event
Malfunction
Summary report: N
ULTRASONIC DISSECTOR
MDR report key: 3960996
·
Received May 23, 2014
Report
- Report Number
- 1717344-2014-00441
- Event Type
- Malfunction
- Date Received
- May 23, 2014
- Report Date
- May 22, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- 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 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 TOTAL LAPAROSCOPIC HYSTERECTOMY, THE DISSECTOR ON THE SYSTEM STOPPED WORKING AND WAS REMOVED FROM THE SURGICAL FIELD. WHILE THE DISSECTOR WAS BEING CLEANED, A PIECE OF THE ACTIVE WAVEGUIDE DISENGAGED FROM THE DISSECTOR. NOTHING FELL INTO THE PT CAVITY AND THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309307 | ULTRASONIC DISSECTOR | ULTRASONIC DISSECTOR | LFL | COVIDIEN LP | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ULTRASONIC REUSABLE GENERATOR, SERIAL #UNK| ULTRASONIC REUSABLE BATTERY PACK, SERIAL #UNK |