BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 6F X 105CM STRAIGHT

    MDR report key: 13082403 · Received December 23, 2021

    Report

    Report Number
    0001625425-2021-01234
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    November 22, 2021
    Report Date
    February 14, 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
    OTHER
    Health Professional
    N

    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 NO DAMAGE TO THE PRODUCT. FUNCTIONALLY, THE DEVICE WOULD EITHER NOT OPEN OR OPEN SLOWLY, THEN SUDDENLY SNAP OPEN. A MAGNIFIED VIEW FOUND THAT ONE OF THE PINS IN THE CLEVIS MECHANISM MAY HAVE BEEN OVER PRESSED, CAUSING AN INTERMITTENT DRAG WHEN TRYING TO ACTUATE THE DEVICE. THE SAMPLES ARE BEING SENT BACK TO THE SUPPLIER FOR FURTHER INVESTIGATION. A SCAR# S-2020-00006 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

    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 NO DAMAGE TO THE PRODUCT. FUNCTIONALLY, THE DEVICE WOULD EITHER NOT OPEN OR OPEN SLOWLY, THEN SUDDENLY SNAP OPEN. A MAGNIFIED VIEW FOUND THAT ONE OF THE PINS IN THE CLEVIS MECHANISM MAY HAVE BEEN OVER PRESSED, CAUSING AN INTERMITTENT DRAG WHEN TRYING TO ACTUATE THE DEVICE. THE SAMPLES ARE BEING SENT BACK TO THE SUPPLIER FOR FURTHER INVESTIGATION. A SCAR 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 DIDN'T OPEN IN BODY. THE JAWZ WAS REPLACED WITH AN ADDITIONALLY OPENED 190075, AND THE PROCEDURE WAS COMPLETED. AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT (B)(4): THERE WAS SOME RESISTANCE IN THE MANIPULATION TO OPEN THE JAWS, THEN THE JAWS OPENED WITH SLOW RESPONSE.

    Description of Event or Problem · 0

    DURING PROCEDURE, A PHYSICIAN STOPPED USING THE JAWZ AS THE JAWS DIDN'T OPEN IN BODY. THE JAWZ WAS REPLACED WITH AN ADDITIONALLY OPENED 190075, AND THE PROCEDURE WAS COMPLETED. AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMKK: THERE WAS SOME RESISTANCE IN THE MANIPULATION TO OPEN THE JAWS, THEN THE JAWS OPENED WITH SLOW RESPONSE.

    Description of Event or Problem · 0

    DURING PROCEDURE, A PHYSICIAN STOPPED USING THE JAWZ AS THE JAWS DIDN'T OPEN IN BODY. THE JAWZ WAS REPLACED WITH AN ADDITIONALLY OPENED 190075, AND THE PROCEDURE WAS COMPLETED. AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMKK: THERE WAS SOME RESISTANCE IN THE MANIPULATION TO OPEN THE JAWS, THEN THE JAWS OPENED WITH SLOW RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981081 JAWZ ENDOMYOCARDIAL BIOPSY FORCEP 6F X 105CM STRAIGHT JAWZ DWZ ARGON MEDICAL DEVICES 190075 5128344 00886333206803

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other