FDA Adverse Event
Malfunction
Summary report: N
COOLSEAL REVEAL
MDR report key: 19948936
·
Received August 9, 2024
Report
- Report Number
- 19948936
- Event Type
- Malfunction
- Date Received
- August 9, 2024
- Date of Event
- June 26, 2024
- Report Date
- July 16, 2024
- Manufacturer
- JUSTRIGHT SURGICAL, LLC / BOLDER SURGICAL
- Product Code
- GEI
- UDI-DI
- 00850346007092
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
COOLSEAL WAS BEING USED BY PHYSICIAN AND THUMB LEVER BROKE OFF, HIT THE PHYSICIAN IN THE HEAD AND FELL ON THE FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1560573 | COOLSEAL REVEAL | ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES | GEI | JUSTRIGHT SURGICAL, LLC / BOLDER SURGICAL | CSL-RV105-10 | 00850346007092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |