inforMED
MalfunctionFFZ

N/A

Received Sep 4, 1992 · Event occurred Jul 29, 1992

Report 1319 · MDR key 1319

Device

Generic name

Bovie Electrical Cord

Manufacturer

Cabot Medical

Model number

N/A

Catalog number

00160501

Lot number

N/A

Patient

36 YR

Narrative

Description of Event or Problem

BOVIE CORD BURNED THROUGH AT POINT OF CONNECTION TO THE COAGULATING INSTRUMENT. EXPOSED WIRE CAUSE A 1 CM X CM BURN TO PATIENT'S LEFT THIGH. BURN WAS DEBRIDED AND DRESSED. LENGTH OF STAY WAS NOT EXTENDED DUE TO BURN. DO NOT BELIEVE THIS OCCURANCE MEETS THE DEFINITION OF SERIOUS ILLNESS OR SERIOUS INJURY. THE BURN WAS NOT SIGNIFICANT ENOUGH TO POSE A THREAT TO BODY FUNCTIONS OR TO CAUSE PERMANENT IMPAIRMENT, HOWEVER, THE DEVICE DID MALFUNCTIONDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: ELECTRICAL PROBLEM - OPEN CIRCUIT, TELEMETRY FAILURE, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.