FDA Adverse Event Other Summary report: N

HAND CONTROLLED PENCIL

MDR report key: 2445480 · Received February 7, 2012

Report

Report Number
MW5024166
Event Type
Other
Date Received
February 7, 2012
Date of Event
January 22, 2012
Report Date
January 31, 2012
Manufacturer
CONMED
Product Code
GEI
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

CAUTERY PENCILS USED FROM LOT# 110815-5, X2 WITH SETTINGS AT USUAL 60 CUT/60 COAG, BURNED PHYSICIAN'S GLOVES WHEN USING SAME. THE FIRST CAUTERY PENCIL USED (SAVED POST-OP AND NUMBERED 1) BURNED A HOLE IN DOCTOR'S TOP GLOVE. THE REPLACEMENT CAUTERY PENCIL (SAVED AND NUMBERED 2) ACTUALLY CAUSED A 'FLAME' (SEEN BY DOCTOR) AND BURNED THROUGH HIS TOP AND BOTTOM GLOVES WORN (RIGHT LONGEST/MID FINGER).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HAND CONTROLLED PENCIL GEI CONMED 110815-5

Patients

Seq Age Sex Outcome Treatment
1 74 YR