BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALVE XS DISS.SCISSORS 15°CVD.235/370MM

    MDR report key: 8418794 · Received March 13, 2019

    Report

    Report Number
    9610612-2019-00176
    Event Type
    Malfunction
    Date Received
    March 13, 2019
    Report Date
    June 8, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    LRW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ASSOCIATED MEDWATCHES: 9610612-2019-00175. MANUFACTURING SITE EVALUATION: THE PRODUCTS WERE PROVIDED DECONTAMINATED AND BEEN FORWARDED TO THE MANUFACTURER FOR INVESTIGATION. FAILURE DESCRIPTION - THE MECHANICS OF THE BLADES OF BOTH PAIRS OF SCISSORS ARE NO LONGER WORKING ACCORDING TO SPECIFICATIONS. THE BLADES CROSS EACH OTHER, THE LIMITATION STOP IS NOT IN PLACE. NO OTHER DEVIATIONS CAN BE FOUND. INVESTIGATION - DURING THE FUNCTION TEST, THE BLADES CROSSED EACH OTHER SINCE THE LIMITATIONS STOPS WERE BROKEN; THE FRAGMENTS WERE NOT AVAILABLE FOR INVESTIGATION. THE MICROSCOPIC INSPECTION OF THE FRACTURE PATTERN ILLUSTRATED A SHEAR FRACTURE DUE TO OVERLOAD. THE MANUFACTURER, DAUSCH MEDIZINTECHNIK GMBH CARRIED OUT FURTHER INVESTIGATIONS. ACCORDING TO THEIR REPORT, THE BREAKAGE OF THE MECHANICS WAS CAUSED BY AN OVERLOAD SITUATION DUE TO CUTTING TOO MUCH AND /OR HARD TISSUE WITH HIGH PRESSURE. BATCH HISTORY REVIEW - THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR ALL AVAILABLE LOT NUMBERS AND FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THESE BATCHES. CONCLUSIONS AND ROOT CAUSE - BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST LIKELY RELATED TO AN INSUFFICIENT USAGE. RATIONALE - ACCORDING TO THE INVESTIGATION REPORT FROM THE MANUFACTURER, THE REASON FOR THE FAILURE WAS DUE TO AN OVERLOAD SITUATION, FOR EXAMPLE TRYING TO CUT HARD TISSUE WITH TOO MUCH FORCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SCISSORS MALFUNCTIONED INTRAOPERATIVELY. DURING A MINIMALLY INVASIVE CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE, WHILE USING A PAIR OF SCISSORS THE BLADES STARTED CROSSING TOO FAR AND WOULD GET STUCK. PER THE REPORTER, BOTH BLADES FALL TO THE SIDE OCCASIONALLY AS YOU OPERATE THE SCISSORS. A SECOND PARIF OF SCISSORS WERE USED, WHICH DEMONSTRATED THE SAME ISSUE. THE SURGERY WAS REPORTED TO HAVE TAKEN A LITTLE LONGER DUE TO OBTAINING A THIRD PAIR OF SCISSORS FROM A DIFFERENT COMPANY TO FINISH THE CASE. NO HARM WAS DONE TO THE PATIENT. NO OTHER INFORMATION HAS BEEN PROVIDED. ASSOCIATED MEDWATCHES: 9610612-2019-00175 .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211451 VALVE XS DISS.SCISSORS 15°CVD.235/370MM SPECIALITIES CARDIO-THORACIC S LRW AESCULAP AG FC370R 52440559

    Patients

    Seq Age Sex Outcome Treatment
    1