FDA Adverse Event
Malfunction
Summary report: N
LIGASURE
MDR report key: 11715205
·
Received April 23, 2021
Report
- Report Number
- 11715205
- Event Type
- Malfunction
- Date Received
- April 23, 2021
- Date of Event
- April 19, 2021
- Report Date
- April 19, 2021
- Manufacturer
- COVIDIEN
- Product Code
- GIE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 0
LIGASURE LF1823 DID NOT FUNCTION- SOUND ACTIVATED BUT NO POWER. CHECK INSTRUMENT SCREEN FLASHING.
Description of Event or Problem · 1
LIGASURE LF1823 DID NOT FUNCTION- SOUND ACTIVATED BUT NO POWER. CHECK INSTRUMENT SCREEN FLASHING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608769 | LIGASURE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GIE | COVIDIEN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28105 DA |