BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOVIEW HEMOPRO 2

    MDR report key: 8512024 · Received April 13, 2019

    Report

    Report Number
    2242352-2019-00426
    Event Type
    Malfunction
    Date Received
    April 13, 2019
    Date of Event
    February 21, 2019
    Report Date
    April 11, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED SECTION: G5 - CHANGED PMA/510(K)# FROM "K052274" TO "K101274". THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF BLOOD AND CLINICAL USE WERE OBSERVED. THE HEATER WERE ON THE HOT JAW WAS OBSERVED TO BENT AND DETACHED FROM THE ENTIRETY OF THE HOT JAW EXCEPT THE BASE, WHERE IT REMAINED ATTACHED. THERE WERE NO SIGNS OF CRACKS OR PEELING OBSERVED ON THE SILICONE INSULATION OF THE JAWS. BASED ON THE RETURNED CONDITION OF THE DEVICE AND THE EVALUATION RESULTS, THE REPORTED FAILURE "MATERIAL TWISTED/BENT" WAS CONFIRMED. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE "MATERIAL TWISTED/BENT" ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET¿S FAILURE INVESTIGATION REPORT (FIR) SYSTEM.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 WIRE HAD BECOME LIFTED OFF OF THE JAWS. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, VASOVIEW HEMOPRO 2 WIRE HAD BECOME LIFTED OFF OF THE JAWS. 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
    305110 VASOVIEW HEMOPRO 2 ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC 25142647

    Patients

    Seq Age Sex Outcome Treatment
    1