FDA Adverse Event Other Summary report: N

AARON

MDR report key: 399259 · Received June 7, 2002

Report

Report Number
1030322-2002-00007
Event Type
Other
Date Received
June 7, 2002
Report Date
May 8, 2002
Manufacturer
AARON MEDICAL INDUSTRIES
Product Code
GEI
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
OK, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

TECHNICIAN WAS CONTROLLING THE POWER SETTINGS WHILE DOCTOR PERFORMED SURGERY ON A HUSKY/GERMAN SHEPARD MIXED BREED DOG WEIGHTING APPROXIMATELY 50 LBS. THE PHYSICIAN COMPLAINED THAT THE UNIT WAS NOT GETTING HOT ENOUGH SO THE TECHNICIAN ADJUSTED THE SETTINGS, INCREASING THE POWER MULTIPLE TIMES. THE TECHNICIAN REPORTED AFTER CONFERRING WITH THE PHYSICIAN THAT THE UNITS SETTINGS USED DURING THE PROCEDURE WERE AS FOLLOWS: COAG AT LEAST 70, CUT OVER 30 AND ON FORCE. CUT/BLEND WAS SET AT THE 2ND LIGHT. WHEN THE PROCEDURE WAS FINISHED AND CLEAN UP WAS TAKING PLACE IT WAS DISCOVERED THAT A BURN HAD OCCURRED ON THE UNDERSIDE OF THE DOG AT THE POINT THE GROUNDING PLATE WAS POSITIONED UNDER THE DOGS SIDE. THE TECHNICIAN REPORTED THAT GEL WAS APPLIED TO THIS AREA BUT WAS NOT SHAVED. THE WOUND SIZE WAS DESCRIBED AS HALF DOLLAR SIZE AND NECROTIZING AND WAS BEING TREATED LIKE A REGULAR WOUND.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 AARON HIGH FREQUENCY ELECTROSURGICAL GENERATOR GEI AARON MEDICAL INDUSTRIES A2100 NA

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Other