BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF COAG. SUCTION TUBE

    MDR report key: 8368473 · Received February 25, 2019

    Report

    Report Number
    1418479-2019-00005
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    January 15, 2019
    Report Date
    January 25, 2019
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GCJ
    UDI-DI
    04055207014813
    PMA / PMN Number
    K971166
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL ATTEMPTS WILL BE MADE TO COLLECT DEVICE INFORMATION FROM THE USER FACILITY. (B)(4) CONSIDERS THIS MATTER OPEN. FOLLOW-UP REPORTS WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 TO PROVIDE FDA WITH NEW/CHANGED INFORMATION. (B)(4). WARNING! DANGER OF EXPLOSION! THERE IS AN EXPLOSION HAZARD IF YOU ACTIVATE THE MONOPOLAR SUCTION TUBE IN AN AIR OR GAS BUBBLE ! THIS WILL RESULT IN THERMAL TISSUE DAMAGE. CAUTION! AVOID EXCESSIVE HF VOLTAGE! DANGER OF INJURY IF INSULATION IS DAMAGED! EXCEEDING THE MAXIMUM RECURRING PEAK VOLTAGE OF THE SUCTION TUBE IN COMBINATION WITH HF SURGICAL DEVICES AND / OR SELECTING THE WRONG MODE CAN DESTROY THE INSULATION, RESULTING IN LEAKAGE CURRENTS. THERMAL TISSUE DAMAGE IS POSSIBLE IN THE PATIENT, USER OR THIRD PARTIES. WARNING! HF SPARKING! INSUFFICIENT DISTANCE BETWEEN LIVE HF PARTS AND OTHER CONDUCTIVE PARTS MAY CAUSE INADVERTENT DAMAGE TO THE TISSUE OR THE INSTRUMENT. DURING ACTIVATION, LIVE HIGH FREQUENCY PARTS OF HF INSTRUMENTS MUST HAVE A SAFETY DISTANCE OF AT LEAST 10 MM FROM THE DISTAL END OF THE ENDOSCOPE/SHEATH. CAUTION! IF PRODUCTS ARE DAMAGED OR INCOMPLETE. POSSIBLE INJURY OF PATIENT, USER OR THIRD PERSON. RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. DO NOT USE PRODUCTS WHICH ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. RETURN DAMAGED PRODUCTS TOGETHER WITH LOOSE PARTS FOR REPAIR. DO NOT ATTEMPT TO DO ANY REPAIRS YOURSELF. ADDITIONAL ATTEMPTS WILL BE MADE TO COLLECT DEVICE INFORMATION FROM THE MANUFACTURER. RWMIC CONSIDERS THIS MATTER OPEN. FOLLOW-UP REPORTS WILL BE SUBMITTED AS REQUIRED.

    Description of Event or Problem · 1

    ON JANUARY 25, 2019,RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) RECEIVED MEDWATCH REPORT # (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED: DURING THE PROCEDURE, SMOKE, A SPARK, AND A FLAME WERE OBSERVED COMING OFF THE BOVIE CORD WHERE IT CONNECTS TO THE HAND PIECE. AFTER THE FLAME, THE BOVIE CORD BROKE IN HALF. EARLIER IN THE CASE, THE STAFF AND SURGEON QUESTIONED THE PERFORMANCE OF THE BOVIE/SUCTION. THEY FELT THAT IT MAY NOT HAVE BEEN WORKING PROPERLY. AS SOON AS THE REGISTERED NURSE (RN) AT THE FIELD OBSERVED THE FLAME, THEY STATED TO EVERYONE IN THE ROOM "FIRE" AND THEN DOUSED THE BOVIE CORD WITH THE SALINE FROM THEIR BACK TABLE (AS PER PROTOCOL). THE CORD WAS REMOVED FOR THE FIELD AND SEQUESTERED. A NEW CORD WAS PLACED ON THE FIELD AND THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THE BOVIE MACHINE, BOVIE PADS, AND THE DRAPES WERE ALL REMOVED AND SEQUESTERED. THERE WAS NO PATIENT INJURY REPORTED. THE SUSPECT MEDICAL DEVICE REPORTED IN THE MEDWATCH REPORT WAS THE SUCTION TUBE (PART NUMBER 8291.102 / LOT NUMBER 256S13). WHAT WAS THE ORIGINAL INTENDED PROCEDURE? MEDIASTINOSCOPY. WHAT PROBLEM DID THE USER HAVE? DEVICE FAILED. IS THIS A LABORATORY DEVICE OR LABORATORY TEST? NO. IN ADDITION, TO THE MEDWATCH REPORT, (B)(4) TWO ADDITIONAL NOTIFICATIONS REGARDING THIS INCIDENT. ON JANUARY 28, 2019, (B)(4) REGULATORY DEPARTMENT RECEIVED A CALL FROM AN EMPLOYEE AT A DIFFERENT (B)(6) FACILITY. THEY REPORTED THAT A FIRE HAD OCCURRED INVOLVING A HF CONNECTION CABLE (PART NUMBER 8106.033) AT A SISTER FACILITY. IT WAS LATER CONFIRMED THAT THIS INCIDENT WAS THE SAME INCIDENT REPORTED IN MEDWATCH REPORT # (B)(4). ADDITIONALLY, ON JANUARY 28, 2019, (B)(4) CUSTOMER SERVICE REPRESENTATIVE RECEIVED A CALL FROM A RICHARD WOLF SALES REPRESENTATIVE, THE FOLLOWING WAS REPORTED: THE CABLE (PART NUMBER 8106.033 / LOT NUMBER UNKNOWN) SEPARATED NEAR THE GENERATOR SIDE AT THE PLASTIC CONNECTOR AND CAUGHT ON FIRE. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. SPECIFICALLY, WAS THE DEVICE BEING USED ON A PATIENT WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO PATIENT OR OTHER PERSONNEL DUE TO ISSUE? UNKNOWN. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? UNKNOWN. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? UNKNOWN. WAS THE SCHEDULED PROCEDURE COMPLETED? UNKNOWN. HOW WAS THE PATIENT ANESTHETIZED? UNKNOWN. DURING FOLLOW UP WITH THE CUSTOMER, THE FOLLOWING INFORMATION WAS PROVIDED: WAS THE CABLE CHECKED FOR DAMAGE, SPECIFICALLY, FOR BRITTLENESS OR CRACKS, WORN PLUG, OR SEPARATION OF THE PLUG PRIOR TO USE? YES, VISUAL INSPECTION. WAS THE CABLE PREVIOUSLY REPAIRED? NO. WAS THE CABLE MODIFIED IN ANY WAY? NO. AT WHAT VOLTAGE WAS THE CABLE BEING OPERATED AT? UNKNOWN. HOW ARE THE CABLES REPROCESSED? AS PER OEM RECOMMENDATION. TWO DEVICES WERE INVOLVED IN THIS INCIDENT: HF CABLE - PART NUMBER 8106.033 / SERIAL NUMBER UNKNOWN (MDR 1418479-2019-00004). SUCTION TUBE - PART NUMBER 8291.102 / LOT NUMBER 256S13 (MDR 1418479-2019-00005).

    Description of Event or Problem · 1

    THE USER FACILITY RETURNED THE DEVICE TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) ON (B)(6) 2019 AND THE DEVICE EVALUATION WAS COMPLETED ON (B)(6) 2019. THE DEVICE WAS VISUALLY, FUNCTIONALLY, ELECTRICALLY EVALUATED. THERE WAS NO PROBLEMS FOUND WITH THE DEVICE. THE PROBLEM WAS IDENTIFIED TO BE WITH THE CABLE (MDR # 1418479-2019-00004); AS A RESULT A PROBABLE ROOT CAUSE WAS NOT DETERMINED. A MANUFACTURING DEFECT WAS NOT IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161031 HF COAG. SUCTION TUBE HF COAG. SUCTION TUBE GCJ RICHARD WOLF GMBH 8291.102 256S13 04055207014813

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Other