FDA Adverse Event
Malfunction
Summary report: N
E-Z CLEAN BLADE 2.5IN
MDR report key: 7877669
·
Received September 14, 2018
Report
- Report Number
- 1721194-2018-00036
- Event Type
- Malfunction
- Date Received
- September 14, 2018
- Date of Event
- July 25, 2018
- Report Date
- August 20, 2018
- Manufacturer
- MEGADYNE MEDICAL PRODUCTS, INC.
- Product Code
- GEI
- UDI-DI
- 10614559100080
- PMA / PMN Number
- K081791
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY THE SURGEON WAS USING A COVIDIEN FT10 ELECTROSURGICAL GENERATOR UNIT (ESU) SERIAL # (B) (4) AND A MEGADYNE BOVIE NEEDLE TIP-LOT #183471 AND ENCOUNTERED A SPARK AND A SMALL FLAME IN THE OPERATING ROOM. STAFF REMOVED THE TIP AND REPLACED IT WITH A REGULAR MEGADYNE BOVIE TIP- LOT# 180191 AND AGAIN ENCOUNTERED SPARKS AND A SMALL FLAME. STAFF REMOVED THE ESU UNIT AND NO ADDITIONAL SPARKS OR FLAME OCCURRED. THE INITIAL UNIT WAS SET AT THIRTY CUT AND THIRTY COAG WHEN THE SPARK OCCURRED. THEN, THE UNIT WAS TURNED DOWN TO TWENTY CUT AND TWENTY COAG WITH THE SAME RESULT. IT IS UNKNOWN IF ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 716717 | E-Z CLEAN BLADE 2.5IN | E-Z CLEAN BLADE 2.5 INCH | GEI | MEGADYNE MEDICAL PRODUCTS, INC. | 10614559100080 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |