FDA Adverse Event Injury Summary report: N

ELECTROSURGICAL PENCIL

MDR report key: 20988 · Received February 23, 1995

Report

Report Number: 20988
Event Type: Injury
Date Received: February 23, 1995
Date of Event: October 27, 1994
Report Date: December 31, 1994
Manufacturer: STERILE CONCEPTS/BIRTCHER
Product Code: BWA
Adverse Event: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

CIRCULATING NURSE NOTICED A TONE LIKE AN ESU THAT WAS KEYED ON. NOBODY WAS STEPPING ON A FOOTSWITCH. THE SCRUB NURSE NOTICED SMOKE COMING FROM THE PATIENTS LEFT LEG. THE SCRUB NURSE PICKED UP THE ESU PENCIL AND HANDED IT TO THE P.A. THE SCRUB NURSE SOAKED A LAP SPONGE IN SOLUTION AND PRESSED IT AGAINST THE STILL SMOKING AREA. THE ESU TONE WAS STILL SOUNDING AS THE P.A. HELD THE ESU PENCIL. NO ATTEMPTS WERE MADE TO PUSH THE ESU PENCIL'S ROCKER SWITCH TO TRY AND STOP THE OPERATION.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ELECTROSURGICAL PENCIL		BWA	STERILE CONCEPTS/BIRTCHER		44071271

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention