FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 2851397
·
Received October 30, 2012
Report
- Report Number
- 3006451981-2012-00189
- Event Type
- Malfunction
- Date Received
- October 30, 2012
- Date of Event
- October 19, 2012
- Report Date
- October 23, 2012
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- 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 INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE DEVICE BLADE BECAME DISLODGED DURING A CYSTECTOMY AND COULD NO LONGER BE USED. ADDITIONAL QUESTIONS HAVE BEEN ASKED TO THE SITE CONTACT IN REGARD TO THE INCIDENT AND DEVICE. THERE WAS NO PATIENT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION WITH THE KNIFE BLADE EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S2EF006X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |