FDA Adverse Event Malfunction Summary report: N

ELECTRODE SURGICAL UNIT, ACTIVE HAND/CONTROL

MDR report key: 24122 · Received July 5, 1995

Report

Report Number: 24122
Event Type: Malfunction
Date Received: July 5, 1995
Date of Event: January 19, 1995
Report Date: February 17, 1995
Manufacturer: BIRTCHER MEDICAL SYSTEMS INC.
Product Code: GEI
Product Problem: Yes
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

WHILE PERFORMING A LAMINECTOMY PROCEDURE THE ESU, ACTIVE HAND/CONTROL, WENT "ON" SPONTANEOUSLY WHILE SEATED IN THE PLASTIC HAND/CONTROL HOLDER. THE ELECTRICAL SURGICAL UNIT WAS IMMEDIATELY DISCONNECTED & REPLACED. NO INJURY OCCURRED; HOWEVER THE POTENTIAL FOR FIRE &/ OR BURNS WAS PRESENT.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, RELATED TO ANOTHER DRUG/DEVICE. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		ELECTRODE SURGICAL UNIT, ACTIVE HAND/CONTROL	GEI	BIRTCHER MEDICAL SYSTEMS INC.	0850-130307	94040782

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Other