FDA Adverse Event
Malfunction
Summary report: N
LIGASURE IMPACT
MDR report key: 3940571
·
Received April 18, 2014
Report
- Report Number
- 3006451981-2014-00604
- Event Type
- Malfunction
- Date Received
- April 18, 2014
- Date of Event
- March 24, 2014
- Report Date
- March 27, 2014
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE #: (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 HAD REPORTED THAT DURING A GASTRECTOMY, THE BLADE OF THE DEVICE BECAME STUCK WHEN THE SURGEON WAS CUTTING. THE SURGEON USED A SURGICAL SCISSORS TO CUT THE TISSUE INSTEAD, AND THERE WAS NO PATIENT INJURY. UPON RECEIPT OF THE DEVICE FOR EVALUATION AT COVIDIEN, A PRELIMINARY INVESTIGATION OF THE DEVICE FOUND THAT THE SPINDLE CAP TAB WAS BROKEN OFF. IT WAS RETURNED LOOSE IN THE BAG WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 238508 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S3DF008X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |