BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYFRECATOR 2000, 115V

    MDR report key: 11495750 · Received March 16, 2021

    Report

    Report Number
    3007305485-2021-00093
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 19, 2021
    Report Date
    April 28, 2021
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE CUSTOMER'S REPORTED ISSUE AND COMPLAINT OF "PATIENT SHOCKED AND JUMPED OFF TABLE" WAS DETERMINED TO BE UNCONFIRMED. AN EVALUATION OF THE RETURNED DEVICE BY THE SERVICE DEPARTMENT FOUND THAT THE UNIT NEEDED AN INSERT TO PROPERLY CONNECT POWER CORD AND TO HAVE THE BRACKET TIGHTENED. THE EVALUATION OF THE DEVICE FOUND NOTHING THAT WOULD CONTRIBUTE TO A "SHOCK". BRACKET ALIGNMENT HAS NO SAFETY IMPACT, IT ONLY SECURES THE POWER TO THE CONSOLE SO THAT THE POWER CORD DOESN'T GET DISCONNECTED INADVERTENTLY. IF THE CORD GETS PARTIALLY DISCONNECTED THERE IS NO EVIDENCE THAT IT WOULD CAUSE A SHOCK TO THE PATIENT. THE SERVICE HISTORY WAS REVIEWED AND NO DATA WAS FOUND. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. (B)(4). THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. THE IFU ALSO ADVISES THE USER THAT THE POWER CORD OF THE ESU SHOULD BE CONNECTED TO A PROPERLY POLARIZED AND GROUNDED POWER SOURCE WHOSE VOLTAGE AND FREQUENCY CHARACTERISTICS ARE COMPATIBLE WITH THOSE LISTED ON THE NAMEPLATE OF THIS ESU. TO AVOID THE RISK OF ELECTRIC SHOCK, THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RECEIVED INTO CONMED'S COMPLAINT SYSTEM FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    CONMED'S TECHNICAL PRODUCT SUPPORT TEAM RECEIVED NOTICE FROM THE CUSTOMER REPORTING ISSUES INVOLVING THE HYFRECATOR 2000, 115V, ITEM # 7-900-115, SERIAL (B)(4) EXPERIENCED (B)(6) 2021 AT (B)(6). IT WAS REPORTED ONLY THAT PATIENT SHOCKED - JUMPED OFF TABLE, SETTING OF 8, LOWERED TO 6, LOWERED TO 3, MONOPOLAR, NO METAL OBJECTS ON PATIENT. TO DATE, ALTHOUGH MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, NO INFORMATION OR CLARIFICATION HAS BEEN PROVIDED. ALTHOUGH THERE IS NO INDICATION THE PATIENT REQUIRED MEDICAL ATTENTION OR INTERVENTION AS A RESULT OF THE DEVICE MALFUNCTION THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS THE PATIENT WAS "SHOCKED AND JUMPED OFF TABLE" AND NO CLARIFICATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396223 HYFRECATOR 2000, 115V ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONSOLIDATED MEDICAL EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other