BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 6F X 105CM STRAIGHT

    MDR report key: 14198960 · Received April 25, 2022

    Report

    Report Number
    0001625425-2022-00994
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    February 18, 2022
    Report Date
    June 21, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    DWZ
    UDI-DI
    00886333206803
    PMA / PMN Number
    K951447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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. NO SAMPLE WAS RETURNED FOR EVALUATION, HOWEVER IMAGES WERE PROVIDED. UPON VIEWING THE IMAGES IT WAS FOUND THAT THE ACTUATING WIRE HAD COME OUT OF THE FERRULE USED TO HOLD IT UNDER THE GRUB SCREW. THEREBY CONFIRMING THE COMPLAINT. A SCAR# SCAR-00026 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.

    Description of Event or Problem · 0

    DURING PROCEDURE, A PHYSICIAN STOPPED USING THE JAWZ AS THE JAWS COULDN'T OPEN/CLOSE IN BODY. AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMKK: UNABLE TO MANIPULATE THE JAWS DUE TO THE BROKEN HANDLE. DETACHED CORE WIRE FROM THE HANDLE WAS FOUND.

    Description of Event or Problem · 0

    DURING PROCEDURE, A PHYSICIAN STOPPED USING THE JAWZ AS THE JAWS COULDN'T OPEN/CLOSE IN BODY AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMKK: UNABLE TO MANIPULATE THE JAWS DUE TO THE BROKEN HANDLE. DETACHED CORE WIRE FROM THE HANDLE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2442251 JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 6F X 105CM STRAIGHT JAWZ ENDOMYOCARDIAL BIOPSY FORCEP DWZ ARGON MEDICAL DEVICES 190075 5156033 00886333206803

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other