FDA Adverse Event
Injury
Summary report: N
LIGASURE ADVANCE PISTOL GRIP
MDR report key: 2081415
·
Received April 29, 2011
Report
- Report Number
- 1717344-2011-00330
- Event Type
- Injury
- Date Received
- April 29, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 7, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER INITIALLY REPORTED THAT DURING A LAPAROSCOPIC COLON PROCEDURE, THE INSULATION BOOT ON THE DEVICE WAS TORN. THE INCIDENT DEVICE WAS RETURNED AND THE INSULATION WAS FOUND TO BE MISSING. THE SITE HAS BEEN NOTIFIED OF THE ISSUE, BUT NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE BY THE SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 194687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |