BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASO VIEW HEMOPRO

    MDR report key: 6501418 · Received April 18, 2017

    Report

    Report Number
    2242352-2017-00390
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 18, 2017
    Manufacturer
    MAQUET CV
    Product Code
    GEI
    PMA / PMN Number
    K052274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. SIGNS OF CLINICAL USAGE AND EVIDENCE OF BLOOD WERE OBSERVED. TISSUE AND CHARRED MATERIAL WAS OBSERVED ON THE JAWS. THE HEATER WIRE WAS FLEXED AWAY FROM THE HOT JAW. IT REMAINED ATTACHED AT THE BASE AND THE TIP OF THE JAW. THE INSULATION ON THE JAWS WERE SLIGHTLY CRACKED, AND FRAYED INDICATING BURN OF DEVICE COMPONENT. AN ELECTRICAL EVALUATION WAS CONDUCTED. A PRE-CAUTERY TEST AS WAS PERFORMED PER THE INSTRUCTION FOR USE WITH A REFERENCE CABLE AND REFERENCE POWER SUPPLY VH-3010 AT LEVEL 2.5. AS SOON AS THE POWER SUPPLY WAS TURNED ON, THE HEMOPRO SELF ACTIVATED IMMEDIATELY. AS PER THE INSTRUCTIONS IN THE IFU, THE TOGGLE WAS MOVED AWAY FROM THE MOST PROXIMAL POSITION BUT THE DEVICE STILL REMAINED ACTIVATED. 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. IT WAS OBSERVED THAT THE TOGGLE ON THE SWITCH WAS STUCK IN THE "ON" POSITION. BASED ON THE RESULTS OF THE EVALUATION, THE REPORTED COMPLAINT FOR ¿DEVICE REMAINS ACTIVATED¿ AND THE ANALYZED FAILURES " BENT WIRE" AND "BURN OF DEVICE OR DEVICE COMPONENT- BOOT BURN " WERE CONFIRMED. SPECIFIC ACTIONS FOR THE CONFIRMED REPORTED FAILURE "DEVICE REMAINS ACTIVATED" IS BEING MAINTAINED AND INVESTIGATED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO PA NOTICED THAT THERE WAS AN ONGOING BEEPING SOUND COMING FROM THE HEMOPRO POWER SUPPLY AFTER HE RELEASED THE ACTIVATION BUTTON ON THE HANDLE. HE REMOVED THE HEMOPRO DEVICE FROM THE PATIENT¿S LEG AND THE CUTTING TIP WAS GLOWING RED, POWER SUPPLY WAS UNPLUGGED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO PA NOTICED THAT THERE WAS AN ONGOING BEEPING SOUND COMING FROM THE HEMOPRO POWER SUPPLY AFTER HE RELEASED THE ACTIVATION BUTTON ON THE HANDLE. HE REMOVED THE HEMOPRO DEVICE FROM THE PATIENT¿S LEG AND THE CUTTING TIP WAS GLOWING RED, POWER SUPPLY WAS UNPLUGGED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284271 VASO VIEW HEMOPRO ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CV 25130885

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR