FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 1062795
·
Received June 17, 2008
Report
- Report Number
- 1717344-2008-00268
- Event Type
- Malfunction
- Date Received
- June 17, 2008
- Date of Event
- May 18, 2008
- Report Date
- May 20, 2008
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
DATE OF INITIAL REPORT: 06/17/2008. TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. FURTHER INFO AND THE SAMPLE HAVE BEEN REQUESTED. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE REPORT STATED THAT THE JAWS ON 2 LIGASURE IMPACT DEVICES SEALED CLOSED DURING A RADICAL PROSTATECTOMY DESPITE CLEANING AND WERE UNABLE TO BE REOPENED. THE FIRST DEVICE WAS REPORTED. REPORT # 1717344-2008-00267.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |