FDA Adverse Event
Malfunction
Summary report: N
STERILE DISP LAP CORD
MDR report key: 2113036
·
Received May 25, 2011
Report
- Report Number
- 1717344-2011-00394
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 26, 2011
- Report Date
- April 26, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- 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 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 A GALLBLADDER SURGERY, A FIRE OCCURRED AT THE BASE OF THE CORD (CLOSE TO THE MACHINE). THE SITE WAS ABLE TO PUT THE FIRE OUT WITHOUT INJURY TO PATIENT OR OPERATING ROOM STAFF. USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STERILE DISP LAP CORD | DISPOSABLE CORD | GEI | COVIDIEN LP (VALLEYLAB) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |