FDA Adverse Event Injury Summary report: N

CONMED

MDR report key: 2181936 · Received August 30, 2007

Report

Report Number: 1720159-2007-00037
Event Type: Injury
Date Received: August 30, 2007
Date of Event: August 7, 2007
Report Date: August 29, 2007
Manufacturer: CONMED ELECTROSURGERY
Product Code: FEH
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE RETURNED DEVICE WAS EVALUATED AND CONFIRMED TO HAVE AN ENERGY BREACH. THE DAMAGE DONE TO THE DEVICE MAKES IT DIFFICULT TO IMPOSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. ADDITIONAL DEVICES OF THE SAME PART NUMBER, AND LOT NUMBER CLOSE TO SUSPECT DEVICE'S LOT NUMBER WERE TESTED. THESE ADDITIONAL TESTS REVEALED NO FAILURES. THIS DEVICE IS BEND-ABLE. IT MAY BE POSSIBLE THAT THE USER USED SOME SORT OF DEVICE/TOOL TO BEND THE PRODUCT, POSSIBLY COMPROMISING THE INSULATION. THE USER FACILITY CANNOT CONFIRM THIS. ANY ADDITIONAL INFO OBTAINED THROUGH OUR INVESTIGATIONS WILL BE FORWARDED TO THE FDA.

Description of Event or Problem · 1

PER THE BIOMED (B)(6), HE STATED THAT DURING SURGERY THIS MORNING A FEMALE PT DEVELOPED A BURN AT THE RIGHT CORNER OF HER MOUTH WHERE THE LIPS MEET FROM A PIN HOLE BREACH THAT THE SURGEON FEELS DEVELOPED IN THE SUCTION COAGULATOR DURING SURGERY - THIS ITEM HAD BEEN CHECKED OUT BEFORE THE SURGERY AND NO DEFECTS WERE DISCOVERED AT THAT TIME. THE PT WAS HAVING HER TONSILS AND ADENOIDS REMOVED. PLASTIC SURGEONS WERE CALLED IN AFTER THE BURN WAS DISCOVERED. THE PT RECEIVED STITCHES AT THE BURN SITE AND WAS MOVED TO RECOVERY. PER THE OPERATING ROOM MANAGER, THE PT IS DOING VERY WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONMED	SUCTION COAGULATOR	FEH	CONMED ELECTROSURGERY	60-6900-001	07AHL003

Patients

Seq	Age	Sex	Outcome	Treatment
1	4 YR		Other\| R