FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT THORACIC
MDR report key: 3170763
·
Received May 22, 2013
Report
- Report Number
- 3006451981-2013-00163
- Event Type
- Malfunction
- Date Received
- May 22, 2013
- Date of Event
- February 11, 2013
- Report Date
- February 18, 2013
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER ORIGINALLY REPORTED THAT THE DEVICE BLADE WOULD NOT ADVANCE OR RETRACT. THE SURGEON OPENED ANOTHER INSTRUMENT IN ORDER TO COMPLETE THE CYSTECTOMY PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS RETURNED FOR EVALUATION WITH THE KNIFE BLADE EXPOSED. ADDITIONAL QUESTIONS HAVE BEEN ASKED TO THE CUSTOMER REGARDING THE DEVICE AND INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 226990 | LIGASURE IMPACT THORACIC | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S2FF018X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |