FDA Adverse Event
Malfunction
Summary report: N
EDGE
MDR report key: 10119315
·
Received June 4, 2020
Report
- Report Number
- 1717344-2020-00580
- Event Type
- Malfunction
- Date Received
- June 4, 2020
- Date of Event
- March 9, 2020
- Report Date
- June 4, 2020
- Manufacturer
- NEW DEANTRONICS LTD
- Product Code
- GEI
- UDI-DI
- 10884524000022
- PMA / PMN Number
- K955836
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THERE WAS FLASH AT THE END OF THE BOVIE TIP. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583726 | EDGE | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | NEW DEANTRONICS LTD | E2450H | 93040078X | 10884524000022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |