BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 8881531 · Received August 10, 2019

    Report

    Report Number
    2242352-2019-00928
    Event Type
    Malfunction
    Date Received
    August 10, 2019
    Date of Event
    June 28, 2019
    Report Date
    August 9, 2019
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GEI
    PMA / PMN Number
    K101274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TRACKWISE # (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 31JUL2019 AND AN INVESTIGATION WAS CONDUCTED ON 13NOV2019. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE WAS OBSERVED. MICROSCOPIC INSPECTION WAS CONDUCTED. BLOOD AND CHARRED TISSUE WAS OBSERVED ON THE HEATER WIRE. THE HEATER WIRE WAS OBSERVED TO BE COMPLETELY FLEXED AWAY FROM THE HOT JAW, REMAINING ATTACHED AT THE BASE, WITH DISCONNECTION AT THE TIP OF THE HOT JAW. NO OTHER VISUAL DEFECTS WERE OBSERVED. BASED ON THE RETURN CONDITION OF THE DEVICE, THE REPORTED FAILURE ¿MATERIAL TWISTED/BENT" WAS CONFIRMED. SPECIFIC ACTIONS FOR THE ANALYZED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S FAILURE INVESTIGATION REPORT (FIR) SYSTEM.

    Description of Event or Problem · 0

    DURING VEIN HARVEST, CLINICIAN NOTICED WIRE BECAME DISLODGED FROM HEMOPRO 2 JAWS. SUMMARY: THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2, THEY NOTICED WIRE BECAME DISLODGED FROMHEMOPRO 2 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

    DURING VEIN HARVEST, CLINICIAN NOTICED WIRE BECAME DISLODGED FROM HEMOPRO 2 JAWS. SUMMARY: THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE USING VASOVIEW HEMOPRO 2, THEY NOTICED WIRE BECAME DISLODGED FROM HEMOPRO 2 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
    675552 EVH ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2 25146389

    Patients

    Seq Age Sex Outcome Treatment
    1