FDA Adverse Event
Malfunction
Summary report: N
LIGASURE
MDR report key: 11398549
·
Received March 2, 2021
Report
- Report Number
- 11398549
- Event Type
- Malfunction
- Date Received
- March 2, 2021
- Date of Event
- November 11, 2020
- Report Date
- February 23, 2021
- Manufacturer
- COVIDIEN LP
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
COVIDIEN LP LIGASURE LF1212A GOT TOO HOT WHILE IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298501 | LIGASURE | ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES | GEI | COVIDIEN LP | LF1212A | SODH719X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23725 DA |