BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 105CM STRAIGHT

    MDR report key: 14742889 · Received June 20, 2022

    Report

    Report Number
    0001625425-2022-01025
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    June 9, 2022
    Report Date
    July 28, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DWZ
    UDI-DI
    00886333206797
    PMA / PMN Number
    K951447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS AVAILABLE FOR RETURN. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN RETURNED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RECEIVED AND REVIEWED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE BATCH RECORDS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION AND NO DEVIATIONS OR ANOMALIES WERE FOUND. ONE OPENED DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION FOUND THAT THE ACTUATING CABLE WAS LOOSE FROM THE GRUB SCREW IN THE SLIDE BODY, RESULTING IN THE SPRING BEING SEPARATED FROM THE DEVICE. THEREBY CONFIRMING THE COMPLAINT. THE SAMPLES ARE BEING SENT BACK TO THE SUPPLIER FOR FURTHER INVESTIGATION. A SCAR# (B)(4)HAS BEEN ISSUED TO NOTIFY THE SUPPLIER VIANT AS&O HOLDINGS, LLC THAT AN INVESTIGATION IS NECESSARY. PER THE SUPPLIER'S INVESTIGATION, THEY WILL TAKE NECESSARY CORRECTIVE MEASURES.

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS INDICATED AS RETURNED. AS OF THE DATE OF THIS REPORT, THE SAMPLE HAS NOT BEEN EVALUATED. A FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN REVIEWED.

    Description of Event or Problem · 0

    THIS DEVICE IS USED FOR OUR HEART BIOPSIES. WE HAD IT IN THE RV OF THE HEART AND THE SPRING WITHIN THE DEVICE BROKE WITH THE BIOPTOME IN THE OPEN POSITION. WE HAD TO USE A GRASPER TO PULL THE WIRE BACK TO CLOSE THE DEVICE AND REMOVE IT FROM THE BODY.

    Description of Event or Problem · 0

    THIS DEVICE IS USED FOR OUR HEART BIOPSIES. WE HAD IT IN THE RV OF THE HEART AND THE SPRING WITHIN THE DEVICE BROKE WITH THE BIOPTOME IN THE OPEN POSITION. WE HAD TO USE A GRASPER TO PULL THE WIRE BACK TO CLOSE THE DEVICE AND REMOVE IT FROM THE BODY.

    Description of Event or Problem · 0

    THIS DEVICE IS USED FOR OUR HEART BIOPSIES. WE HAD IT IN THE RV OF THE HEART AND THE SPRING WITHIN THE DEVICE BROKE WITH THE BIOPTOME IN THE OPEN POSITION. WE HAD TO USE A GRASPER TO PULL THE WIRE BACK TO CLOSE THE DEVICE AND REMOVE IT FROM THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029145 JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 6F X 105CM STRAIGHT JAWZ ENDOMYOCARDIAL BIOPSY FORCEP DWZ ARGON MEDICAL DEVICES 190070 5185412 00886333206797

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R