FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT THORACIC
MDR report key: 2190083
·
Received June 30, 2011
Report
- Report Number
- 1717344-2011-00528
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 9, 2011
- Report Date
- June 16, 2011
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A RENAL ANEURYSM, THE DEVICE BECAME DEFECTIVE. THE DEVICE WAS RETURNED WITH THE KNIFE BLADE EXPOSED. ADD'L QUESTIONS HAVE BEEN ASKED REGARDING THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT THORACIC | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 207361LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |