FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 3983221
·
Received June 27, 2014
Report
- Report Number
- 3006451981-2014-00656
- Event Type
- Malfunction
- Date Received
- June 27, 2014
- Date of Event
- May 20, 2014
- Report Date
- June 3, 2014
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 REPORTED THAT DURING A BOWEL RESECTION, THE JAWS OF THE DEVICE WOULD NOT REOPEN WHILE APPLIED TO TISSUE. THE SURGEON USED GRASPERS TO REOPEN THE JAWS OF THE DEVICE. THERE WAS NO UNANTICIPATED BLEEDING OR TISSUE DAMAGE, AND NO HARM TO THE PT. ANOTHER DEVICE WAS OPENED AND USED TO CONTINUE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377309 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYS | GEI | COVIDIEN LLC (SHANGHAI) | S3F008X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |