BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP CONTROL

    MDR report key: 8337371 · Received February 13, 2019

    Report

    Report Number
    1418479-2019-00002
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Report Date
    January 14, 2019
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    PMA / PMN Number
    K170377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE LABELING WAS REVIEWED FOR PATIENT CODE AND DEVICE CODES, SEE BELOW: PATIENT CODE: NOT APPLICABLE, NO PATIENT PROBLEM WAS REPORTED. DEVICE CODE: IFU WAS REVIEWED. CAUTION! DO NOT COMBINE PRODUCTS INCORRECTLY! INJURIES OF THE PATIENT, USER OR OTHERS AS WELL AS DAMAGE TO THE PRODUCT ARE POSSIBLE. THE DIFFERENT PRODUCTS CAN ONLY BE USED TOGETHER IF THEIR INTENDED USES AND RELEVANT TECHNICAL DATA (SUCH AS WORKING LENGTH, DIAMETER, PEAK VOLTAGE, ETC.) ARE THE SAME. FOLLOW THE INSTRUCTION MANUALS OF THE PRODUCTS USED IN COMBINATION WITH THIS PRODUCT. FOLLOW THE "NOTES AND INSTRUCTIONS ON HF APPLICATIONS", ORDER NO.: GA-S 002 AS WELL AS THE MANUAL FOR SURGITRON" RADIO FREQUENCY DEVICE , ORDER NO.: GA-A 208 AND SURGI-MAX PLUS, ORDER NO.: GA-A 260. CAUTION! THE PRODUCTS HAVE ONLY LIMITED STRENGTH! EXCESSIVE FORCE WILL CAUSE DAMAGE, IMPAIR THE FUNCTION AND THEREFORE ENDANGER THE PATIENT. IMMEDIATELY BEFORE AND AFTER EACH USE, CHECK THE PRODUCTS FOR DAMAGE, LOOSE PARTS AND COMPLETENESS. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. INSERT RF INSTRUMENTS INTO THE ENDOSCOPE AND WITHDRAW THEM FROM THE LATTER ONLY WITH THE ELECTRODE IN THE RETRACTED POSITION. WARNING! DO NOT REPROCESS DISPOSABLE ITEMS! THE SERVICE LIFE OF PRODUCTS MARKED AS DISPOSABLE, I.E. FOR ONE SINGLE USE ONLY, HAS BEEN DESIGNED FOR ONLY ONE USE IN OR ON A SINGLE PATIENT. IF DISPOSABLE ITEMS ARE REPROCESSED TO BE USED AGAIN, THIS MAY IMPAIR/CHANGE THE PRODUCT PROPERTIES AND THEREFORE ENDANGER THE PATIENT, USER AND OTHERS. CAUTION! IRRIGATION FLUID CAN BE ELECTRICALLY CONDUCTIVE! DEPENDING ON THE APPLICATION THE USER MUST SELECT A SUITABLE IRRIGATION FLUID. USE CONDUCTIVE IRRIGATION FLUIDS, E.G. 0,9% NACL SOLUTION (SALINE). CAUTION! TEMPERATURE INCREASE WHEN WORKING WITHOUT IRRIGATION FLUID! TISSUE DAMAGE DUE TO HIGH TEMPERATURES ENDANGERS THE PATIENT. ACTIVATE THE PRODUCTS ONLY WHILE IMMERSED IN IRRIGATION FLUID AND UNDER CONTINUOUS IRRIGATION. WARNING! DANGER OF INJURY IF THE RF INSTRUMENT IS NOT VISIBLE THROUGH THE SCOPE! INADVERTENT TISSUE DAMAGE AS WELL AS DAMAGE TO THE DISTAL END OF THE ENDOSCOPE AND INSTRUMENT PARTS IS POSSIBLE. USE RF INSTRUMENTS ONLY WITHIN THE SCOPE OF THEIR SPECIFICATIONS (VOLTAGE STRENGTH, MODE). ACTIVATE RF INSTRUMENTS ONLY WHEN THE PART CONDUCTING RF CURRENT HAS BECOME FULLY VISIBLE THROUGH THE SCOPE AND CONTACT IS MADE WITH THE APPLICATION AREA. CAUTION! EXCESSIVE RF VOLTAGE! DANGER OF INJURY FROM DAMAGED INSULATION ON RF INSTRUMENTS! EXCEEDING THE MAXIMUM RECURRING PEAK VOLTAGE OF THE RF INSTRUMENT IN CONJUNCTION WITH RF SURGICAL DEVICES AND/OR SELECTING THE WRONG MODE CAN DESTROY THE INSULATION AND CAUSE LEAKAGE CURRENTS. THE PATIENT, USER OR OTHERS CAN SUFFER THERMAL TISSUE DAMAGE. USE RF INSTRUMENTS IN CONJUNCTION WITH RF SURGICAL DEVICES ONLY AT A MAX. RECURRING PEAK VOLTAGE OF 400 VP. WARNING! RF SPARKING! DANGER OF INJURY DUE TO INCORRECT RF APPLICATION AND INSUFFICIENT DISTANCE BETWEEN PARTS CONDUCTING HIGH FREQUENCY CURRENT AND OTHER CONDUCTIVE PARTS. PARTS CONDUCTING HIGH FREQUENCY CURRENT IN RF INSTRUMENTS MUST HAVE A SAFETY DISTANCE OF AT LEAST 10 MM FROM THE DISTAL END OF THE ENDOSCOPE (X) BEFORE ACTIVATION. CAUTION! WRONG SELECTION OF RF OUTPUT POWER! INJURIES TO THE PATIENT AS WELL AS DAMAGE TO THE PRODUCT ARE POSSIBLE. THE POWER SHOULD BE SET ON THE BASIS OF THE SURGEON'S EXPERIENCE AND TRAINING IN VIEW OF THE CORRESPONDING INDICATION. OBSERVE THE INCREASED VOLTAGE IN THE CASE OF BIPOLAR CUTTING MODES. CAUTION! BE CAREFUL IF PRODUCTS ARE DAMAGED OR INCOMPLETE! INJURIES OF THE PATIENT, USER AND OTHERS ARE POSSIBLE. RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE. DO NOT USE THE PRODUCTS IF THEY ARE DAMAGED, INCOMPLETE OR HAVE LOOSE PARTS. DO NOT ATTEMPT TO DO ANY REPAIRS YOURSELF. CHECK THE PRODUCTS AND THE ACCESSORIES FOR: DAMAGE, SHARP EDGES, LOOSE OR MISSING PARTS, ROUGH SURFACES. ANY INSCRIPTIONS OR IDENTIFICATION NECESSARY FOR THE SAFE INTENDED USE MUST BE LEGIBLE. ATTEMPTS WERE MADE TO COLLECT ADDITIONAL/MISSING INFORMATION FROM THE USER FACILITY, BUT NO ADDITIONAL INFORMATION COULD BE PROVIDED. RWMIC CONSIDERS THIS CASE CLOSED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE USER FACILITY RETURNED THE DEVICE TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC) ON FEBRUARY 19, 2019. THE DEVICE WAS SENT TO THE MANUFACTURE AND THE EVALUATION WAS COMPLETED ON MAY 03, 2019. THE DEVICE APPEARED TO BE USED, THERE WAS MASSIVE WEAR OF THE INSULATION AND THERMAL DAMAGES. THE DEVICE WAS VISUALLY EVALUATED AND THE REPORTED CONDITION, PLASTIC COATING STARTED TO FRAY AND TIP SEPARATED, WAS VERIFIED. THE DEVICE DID NOT MEET SPECIFICATIONS. PROBABLE ROOT CAUSE WAS DETERMINED TO BE USER ERROR/MISUSE. THE INSTRUCTION OF USE INCLUDES MECHANICAL, ELECTRICAL, AND THERMAL CONDITIONS, WHICH MAY RESULT IN SUCH DAMAGES. WARNINGS THAT SHOULD PREVENT THESE CONDITIONS. BY FOLLOWING GIVEN INSTRUCTIONS THESE DAMAGES SHOULD NOT OCCUR.

    Additional Manufacturer Narrative · 1

    (B)(4) CONSIDERS THIS CASE OPEN. THE MANUFACTURE AND USER FACILITY WILL BE CONTACTED TO COLLECT MISSING INFORMATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE USER FACILITY REPORTED THE FOLLOWING TO (B)(4): WHILE BEING USED ON A PROCEDURE, THE PLASTIC COATING THAT PROTECTS THE ELECTRODE STARTED TO FRAY THEN THE TIP SEPARATED, THE MATERIAL THAT SEPARATES THE TIP SIDE TO SIDE MELTED OUT FROM THE CENTER AND THE PROBE WAS RENDERED INOPERABLE. 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? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED THAT PUT THE PATIENT AT RISK? NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? YES. WAS THE SCHEDULED PROCEDURE COMPLETED? YES. HOW WAS THE PATIENT ANESTHETIZED? UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130528 TIP CONTROL ENDOSCOPIC ELECTROSURGICAL ELECTRODE, BIPOLAR, SINGLE-USE GEI RICHARD WOLF GMBH 49936911 73157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention