FDA Adverse Event
Injury
Summary report: N
LIGASURE IMPACT
MDR report key: 3230037
·
Received July 12, 2013
Report
- Report Number
- 3006451981-2013-00225
- Event Type
- Injury
- Date Received
- July 12, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 20, 2013
- Manufacturer
- COVIDIEN LLC (SHANGHAI)
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN REFERENCE NUMBER: (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 THE KNIFE BLADE OF THE DEVICE WOULD NOT ADVANCE. THERE WAS NO INJURY TO THE PATIENT REPORTED. UPON RECEIPT OF THE DEVICE AT COVIDIEN, A PRELIMINARY INVESTIGATION FOUND THAT A TAB FROM THE SPINDLE CAP LOCATED INSIDE OF THE DEVICE HANDLE WAS BROKEN OFF. THE LOCATION OF THE MISSING PIECE IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322535 | LIGASURE IMPACT | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LLC (SHANGHAI) | S3AF030PX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |