FDA Adverse Event
Injury
Summary report: N
LIGASURE VESSEL SEALING SYSTEM
MDR report key: 2232417
·
Received August 26, 2011
Report
- Report Number
- 1717344-2011-00754
- Event Type
- Injury
- Date Received
- August 26, 2011
- Date of Event
- July 27, 2011
- Report Date
- August 5, 2011
- Manufacturer
- COVIDIEN LP (US SURGICAL)
- Product Code
- GEI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE SITE HAS INDICATED THAT THE INCIDENT SAMPLE HAS BEEN DISCARDED. IF ADD'L INFO PERTINENT TO THE INDICATOR IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD, BUT SEALING WAS NOT COMPLETE. SEVERAL TIMES THE DEVICE FAILED TO CLOSE THE VESSELS. AT THE END OF THE PROCEDURE, ONE VESSEL THAT HAD BEEN SEALED OPENED AND BLEEDING OCCURRED. THE SURGERY WAS THEN CONVERTED TO OPEN. A SECOND GENERATOR WAS BROUGHT IN TO ASSIST IN THE COMPLETION OF THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGASURE VESSEL SEALING SYSTEM | LAP VESSEL SEALING INSTRUMENT | GEI | COVIDIEN LP (US SURGICAL) | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other| R | SN (B)(4)| FORCE TRIAD ELECTROSURGICAL GENERATOR |