FDA Adverse Event
Malfunction
Summary report: N
LIGASURE PRECISE+
MDR report key: 3970198
·
Received April 29, 2014
Report
- Report Number
- 1717344-2014-00372
- Event Type
- Malfunction
- Date Received
- April 29, 2014
- Date of Event
- April 28, 2014
- Report Date
- April 28, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING SURGERY, THE KNIFE BLADE CAME OUT OF THE TRACK AND WAS EXPOSED. NO PATIENT INJURY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256327 | LIGASURE PRECISE+ | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | 33530158X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |