FDA Adverse Event
Malfunction
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 3150281
·
Received May 30, 2013
Report
- Report Number
- 1717344-2013-00390
- Event Type
- Malfunction
- Date Received
- May 30, 2013
- Date of Event
- March 19, 2013
- Report Date
- May 23, 2013
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE KNIFE BLADE BECAME STUCK IN THE JAWS WHILE THE DEVICE WAS OUTSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED FOR INSPECTION AND IT WAS NOTICED THAT THE WEBBING WAS PROTRUDING FROM BOTH SIDES OF THE HINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238022 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |