FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 3940651
·
Received April 21, 2014
Report
- Report Number
- 1717344-2014-00337
- Event Type
- Malfunction
- Date Received
- April 21, 2014
- Date of Event
- March 27, 2014
- Report Date
- March 27, 2014
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE #: (B)(4). THE SAMPLE HAS BEEN REQUESTED, BUT 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 THE CLEAR INSULATION BUNCHED UP AND PARTIALLY CAME OFF DURING A HAND-ASSISTED LAPAROSCOPIC COLECTOMY. NOTHING DISENGAGED FROM THE DEVICE DURING THE SURGERY. THERE WAS NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241110 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | 32560012X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR |