FDA Adverse Event
Malfunction
Summary report: N
ULTRASONIC DISSECTOR QTY OF 6
MDR report key: 3002653
·
Received February 13, 2013
Report
- Report Number
- 1717344-2013-00091
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 11, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- LFL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 WHILE DISSECTING THE VAGINAL CUFF DURING A HYSTERECTOMY, THE ACTIVE BLADE CAME IN CONTACT WITH A METAL CLAMP SEVERAL TIMES AND A PIECE OF THE BLADE EVENTUALLY DISENGAGED INTO THE PT CAVITY. THE PIECE WAS RETRIEVED AND THER WAS NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63921 | ULTRASONIC DISSECTOR QTY OF 6 | ULTRASONIC DISSECTION SYSTEM | LFL | COVIDIEN LP | 240397X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ULTRASONIC REUSABLE GENERATOR: SERIAL # UNKNOWN| ULTRASONIC REUSABLE BATTERY PACK: SERIAL # UNKNOWN |