FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2140708
·
Received June 15, 2011
Report
- Report Number
- 1717344-2011-00482
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Date of Event
- May 25, 2011
- Report Date
- June 1, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SITE INDICATED THAT THE INCIDENT SAMPLE WAS DISCARDED. 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 PELVIC EXENTERATION, THE DEVICE BECAME LOCKED ON TISSUE. THERE WAS NO PATIENT INJURY. THE SITE CONTACT INDICATED THAT THEY HAVE NO ADDITIONAL INFORMATION REGARDING THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |