FDA Adverse Event Summary report: N

ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND-CONTROLLED

MDR report key: 9836 · Received August 2, 1993

Report

Report Number: 9836
Date Received: August 2, 1993
Report Date: July 23, 1993
Manufacturer: VALLEY LAB, INC.
Product Code: HQQ
Report Source: User Facility report

Narratives

Description of Event or Problem · 1

WHILE USING THE PENCIL FOR CAUTERIZATION, THE PENCIL CONTINUED TO WORK EVEN AFTER IT WAS TURNED OFF. THE SWITCH APPEARED TO BE STUCK. THE PENCIL CORD HAD TO BE CUT IN ORDER TO REMOVE THE PENCIL FROM THE STERILE FIELD. THE PATIENT SUSTAINED A BURN WHICH HAD TO BE EXCISED AND CLOSED.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	ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND-CONTROLLED		HQQ	VALLEY LAB, INC.	E2502

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Invalid Data