FDA Adverse Event
Malfunction
Summary report: N
ULTRASONIC DISSECTOR QTY OF 6
MDR report key: 3002669
·
Received February 13, 2013
Report
- Report Number
- 1717344-2013-00090
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- February 12, 2013
- Report Date
- February 12, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 TOTAL LAPAROSCOPIC-ASSISTED HYSTERECTOMY PART OF THE ACTIVE BLADE DISENGAGED AND FELL INTO THE PT CAVITY. THE PIECE WAS RETRIEVED. THERE WAS NO PT INJURY. THE SURGICAL STAFF INSTALLED ANOTHER DISSECTOR AND SUCCESSFULLY COMPLETED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63915 | ULTRASONIC DISSECTOR QTY OF 6 | ULTRASONIC DISSECTION SYSTEM | LFL | COVIDIEN LP | 243696X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ULTRASONIC REUSABLE BATTERY PACK: SERIAL # UNKNOWN| ULTRASONIC REUSABLE GENERATOR: SERIAL # UNKNOWN |