BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 5521134 · Received March 23, 2016

    Report

    Report Number
    2242352-2016-00274
    Event Type
    Malfunction
    Date Received
    March 23, 2016
    Date of Event
    February 24, 2016
    Report Date
    February 25, 2016
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. EVIDENCE OF CLINICAL USE AND EVIDENCE OF BLOOD WERE OBSERVED. A VISUAL INSPECTION WAS CONDUCTED. THE SILICONE INSULATION WAS CHARRED AND PARTIALLY REMOVED FROM THE HOT JAW. THE SILICONE INSULATION ON THE COLD JAW WAS TORN AWAY FROM THE TIP AND IT ONLY REMAINED ATTACHED AT THE BASE OF THE COLD JAW. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST AS WAS PERFORMED PER THE INSTRUCTION FOR USE (IFU) WITH A REFERENCE CABLE AND REFERENCE POWER SUPPLY (B)(4) AT LEVEL 2.5. THE DEVICE PASSED THE PRE-CAUTERY TEST; IT PRODUCED VISIBLE STEAM DURING SEVERAL ACTIVATIONS OVER A PERIOD OF 10 MINUTES AND SHUT OFF WHEN THE TOGGLE WAS RELEASED. THE PRE-CAUTERY TEST WAS REPEATED 10 TIMES WHILE THE CABLE CONNECTIONS WERE MANIPULATED WITH NO OBSERVED FAILURE. THE HANDLE WAS OPENED TO EVALUATE THE INTERNAL COMPONENTS. NO VISIBLE DEFECTS WERE OBSERVED TO THE TOGGLE. THE SWITCH WAS EXAMINED UNDER MICROSCOPY. NO RESIDUE OR CONTAMINATION WAS SEEN ON THE SWITCH. WE WERE UNABLE TO OBSERVE ANY ELECTRICAL ISSUES OR FAILURE TO ENERGIZE FOR THE COMPLAINT UNIT DURING OUR TESTING. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT FOR ¿DEVICE REMAINED ACTIVATED¿ WAS UNABLE TO BE CONFIRMED. BASED ON THE CONDITION OF THE DEVICE AS FOUND, THE COMPLAINT WAS CONFIRMED FOR PEELED JAW. SPECIFIC ACTIONS FOR THIS FAILURE MODE ARE BEING MANAGED AND DOCUMENTED IN THE MAQUET CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    Description of Event or Problem · 1

    (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO SELF ACTIVATED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING. (B)(4). HEMOPRO SELF ACTIVATED BEFORE USE.

    Description of Event or Problem · 1

    (B)(4). COMPLAINT 3 OF 4. SEE RELATED COMPLAINTS (B)(4). THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO SELF ACTIVATED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT IS RETURNING. (B)(4). HEMOPRO SELF ACTIVATED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176826 VASO VIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25121999

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR