FDA Adverse Event
Malfunction
Summary report: N
LIGASURE MARYLAND JAW LAPAROSCOPIC SEALER/DIVIDER
MDR report key: 12377205
·
Received August 26, 2021
Report
- Report Number
- MW5103529
- Event Type
- Malfunction
- Date Received
- August 26, 2021
- Date of Event
- August 24, 2021
- Report Date
- August 24, 2021
- Manufacturer
- COVIDIEN LLC / COVIDIEN
- Product Code
- GEI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
FOLLOWING ONLY A FEW ACTIVATIONS, THE HANDLES TO THE LIGASURE BECAME VERY DIFFICULT TO MOVE. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1272428 | LIGASURE MARYLAND JAW LAPAROSCOPIC SEALER/DIVIDER | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | COVIDIEN LLC / COVIDIEN | LF1937 | 114570180X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |