FDA Adverse Event Summary report: N

MEDICHOICE CAUTERY CORDLESS HIGH TEMPERATURE

MDR report key: 1113203 · Received August 13, 2008

Report

Report Number
1113203
Date Received
August 13, 2008
Date of Event
June 3, 2008
Report Date
August 13, 2008
Manufacturer
OWENS & MINOR, INC.
Product Code
GEI
Report Source
User Facility report
Reporter Location
MN, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THREE SHAVED BIOPSY/EXISIONS WERE TO BE PERFORMED. EACH AREA WAS SHAVED LIGHTLY AND CLEANSED. THE FIRST TWO LESIONS WERE SHAVED OFF OF THE PATIENT'S LEFT TEMPLE AND CAUTERIZED WITH HEAT CAUTERY WITHOUT ANY INCIDENT. AS THE PHYSICIAN WAS CAUTERIZING THE THIRD LESION AT THE APEX OF THE SCALP, IT WAS NOTED THAT A BRAND NEW CAUTERY INSTRUMENT WAS GLOWING INTENSELY FROM THE HEAT. AS THE PHYSICIAN APPLIED THE CAUTERY, IT WAS NOTICED THAT THE PATIENT'S HAIRS WERE SINGED FROM THIS HEAT. THE PHYSICIAN PULLED THE CAUTERY AWAY AND OBSERVED THAT THE HAIRS CONTINUED TO SINGE AND BURN, AS THOUGH THERE WAS STILL HEAT BEING APPLIED. THE PATIENT SAT UP SUDDENLY AND COMPLAINED OF SOME HEAT ON THE BACK OF HIS/HER HEAD. IT WAS DISCOVERED THAT A 4X4 GAUZE HAD SLIPPED BENEATH THE FENESTRATED DRAPE AND HAD A GLOWING EMBER, ALTHOUGH THERE WERE NO OPEN FLAMES YET. THE GAUZE THEN FELL TO THE PATIENT'S PILLOW AND BROKE INTO FLAME, BUT NONE OF THIS OPEN FLAME TOUCHED THE PATIENT. THE PILLOW AND INVOLVED DRAPES AND GAUZE WERE IMMEDIATELY DOUSED WITH WATER IN THE SINK, AND IN THIS WAY THE FIRE WAS PUT OUT. THE PATIENT AND HIS/HER CLOTHING HAD NO APPARENT INJURY OR DAMAGE. HOWEVER, AS A PRECAUTION A COLD, WET COMPRESS WAS APPLIED TO THE RIGHT BASE OF THE NECK WHERE THE PATIENT HAD INITIALLY FELT SOME WARMTH. OTHER THAN A FEW SINGED HAIRS AROUND THE MOLE AT THE APEX OF THE SCALP, THERE WAS NO EVIDENCE OF ANY BURNS OR DAMAGE TO THE PATIENT'S SKIN OR HAIR. THE NEXT DAY, THE PHYSICIAN CONTACTED THE PATIENT IN A FOLLOW UP PHONE CALL AND THE PATIENT REPORTED THAT HE/SHE DID NOT GET HURT NOR WERE THERE ANY VISIBLE BURNS. THE PATIENT REPORTED HAVING HAD APPLIED BUG SPRAY WITH DEET AND SPRAYING THE HEAD/HAIR, BUT DID NOT APPLY HAIR SPRAY OR OTHER PRODUCTS. THE PLAN IS THAT PATIENTS SCHEDULED FOR SCALP PROCEDURES WILL BE ASKED TO AVOID ANY BUG SPRAY OR HAIR SPRAY USE THAT DAY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDICHOICE CAUTERY CORDLESS HIGH TEMPERATURE CAUTERY GEI OWENS & MINOR, INC. * 1006-4

Patients

Seq Age Sex Outcome Treatment
1 50 YR