BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A3213, CLAMP (SIZE 5-30)

    MDR report key: 19630175 · Received June 27, 2024

    Report

    Report Number
    2027111-2024-00720
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Report Date
    October 10, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXC
    UDI-DI
    00607915112691
    PMA / PMN Number
    K950492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS ANTICIPATED TO RETURN TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED UNIT CONFIRMED MISALIGNED JAWS. THIS CONFIRMS THE COMPLAINANT¿S EXPERIENCE OF A LOOSE BOX LOCK. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY WEAR AND TEAR ON THE DEVICE. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO TRENDS WERE IDENTIFIED. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL. THIS EVENT WAS INITIALLY REPORTED BASED ON THE DESCRIPTION OF THE EVENT. HOWEVER, BASED ON THE EVALUATION OF THE RETURNED UNIT, APPLIED MEDICAL DETERMINED THAT THIS EVENT IS NOT REPORTABLE AS IT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: [NI] EVENT DESCRIPTION: [HOSPITAL: [HOSPITAL NAME], PRODUCT: A3213, COMPLAINT 1 OF 4: 2024-001553 MODEL #A3213 LOT # UNKNOWN, COMPLAINT 2 OF 4: 2024-001554 MODEL #A3213 LOT # UNKNOWN, COMPLAINT 3 OF 4: 2024-001555 MODEL #A3213 LOT # UNKNOWN, COMPLAINT 4 OF 4: 2024-001556 MODEL #A3213 LOT # UNKNOWN. [HOSPITAL NAME] THE CARDIOVASCULAR SURGEON STOPPED THE REP IN THE MIDDLE OF THE HOSPITAL HALLWAY TO STATE THAT THEY HAD SOME CLAMPS THAT WERE SCISSORING AT THE TIPS. NO SPECIFIC EVENT/CASE WAS MENTIONED. THE REP INSPECTED THE HOSPITAL'S SEVEN CLAMPS, AND FOUND THAT FOUR OF THE CLAMPS WERE LOOSE. THERE WAS NO LOSS OF OCCLUSION WHEN USING THE CLAMPS, THE SURGEON JUST HAD TO BE MORE VIGILANT. IN ONE CASE, HE REPLACED A CLAMP WITH A NEW ONE. THERE ARE NO PATIENT INJURIES INVOLVED WITH THIS COMPLAINT. INSERTS WERE ABLE TO BE ATTACHED TO THE CLAMPS. THE INSERTS WOULD NOT FALL OFF, BUT THEY WOULD MISALIGN DUE TO THE CLAMP SCISSORING. THE LOT NUMBERS ARE UNKNOWN. THE PRODUCT IS AVAILABLE FOR RETURN.] TYPE OF INTERVENTION: [SURGEON WOULD USE A NEW CLAMP IF NEEDED.] PATIENT STATUS [NO PATIENT INJURY.]

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: NI EVENT DESCRIPTION: PRODUCT: A3213 COMPLAINT 1 OF 4: (B)(4) MODEL #A3213 LOT # 1480187 1EA; COMPLAINT 2 OF 4: (B)(4) MODEL #A3213 LOT # 1480187 1EA; COMPLAINT 3 OF 4: (B)(4) MODEL #A3213 LOT # 1457736 1EA; COMPLAINT 4 OF 4: (B)(4) MODEL #A3213 LOT # 1457736 1EA. [HOSPITAL NAME]. THE CARDIOVASCULAR SURGEON STOPPED THE REP IN THE MIDDLE OF THE HOSPITAL HALLWAY TO STATE THAT THEY HAD SOME CLAMPS THAT WERE SCISSORING AT THE TIPS. NO SPECIFIC EVENT/CASE WAS MENTIONED. THE REP INSPECTED THE HOSPITAL'S SEVEN CLAMPS, AND FOUND THAT FOUR OF THE CLAMPS WERE LOOSE. THERE WAS NO LOSS OF OCCLUSION WHEN USING THE CLAMPS, THE SURGEON JUST HAD TO BE MORE VIGILANT. IN ONE CASE, HE REPLACED A CLAMP WITH A NEW ONE. THERE ARE NO PATIENT INJURIES INVOLVED WITH THIS COMPLAINT. INSERTS WERE ABLE TO BE ATTACHED TO THE CLAMPS. THE INSERTS WOULD NOT FALL OFF, BUT THEY WOULD MISALIGN DUE TO THE CLAMP SCISSORING. THE LOT NUMBERS ARE UNKNOWN. THE PRODUCT IS AVAILABLE FOR RETURN. TYPE OF INTERVENTION: SURGEON WOULD USE A NEW CLAMP IF NEEDED. PATIENT STATUS. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2175019 A3213, CLAMP (SIZE 5-30) CLAMP, VASCULAR DXC APPLIED MEDICAL RESOURCES A3213 1457736 00607915112691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown