FDA Adverse Event
Malfunction
Summary report: N
NEW LIGASURE 5MM
MDR report key: 1894767
·
Received November 5, 2010
Report
- Report Number
- 1717344-2010-00787
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- September 15, 2010
- Report Date
- September 28, 2010
- Manufacturer
- COVIDIEN LP (VALLEYLAB)
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ONE USED (B)(4) DEVICE WAS RETURNED FOR EVAL. WHEN TESTING THE SEALING FUNCTION, THE INSTRUMENT SELF-ACTIVATED IN AN OPEN CIRCUIT CONDITION. THE CAUSE OF THE SELF-ACTIVATION IS DUE TO AN EXTENDED TAB ON THE SWITCH COVER. COVIDIEN HAS IMPLEMENTED A NEW SWITCH COVER WITH A SHORTER TAB. THIS DEVICE WAS MFG PRIOR TO THIS CHANGE BEING IMPLEMENTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING SURGERY PREPARATION, THE DEVICE ACTIVATED WITHOUT THE BUTTON BEING PUSHED. THE DEVICE WAS NEVER IN CONTACT WITH A PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEW LIGASURE 5MM | LIGASURE VESSEL SEALING SYSTEM | GEI | COVIDIEN LP (VALLEYLAB) | 190465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |