BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX

    MDR report key: 19521513 · Received June 12, 2024

    Report

    Report Number
    2027111-2024-00690
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Report Date
    August 13, 2024
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FZP
    PMA / PMN Number
    K011236
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF THE HARM RESULTING FROM THIS EVENT HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS NOT ANTICIPATED TO RETURN TO APPLIED MEDICAL. A FOLLOW UP REPORT WILL BE PROVIDED FOLLOWING THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UNK. EVENT DESCRIPTION: COMPLAINTS 2024-001428 - 2024-001437 NCL. COMPLAINTS 2024-001438 - 2024-001447 CLIP SCISSORED. COMPLAINTS 2024-001448 - 2024-001457 INCOMPLETE CLIP CLOSURE. HOSPITAL: [INSTITUTION] INFORMATION RECEIVED FROM [NAME] VIA EMAIL ON 14MAY2024: OVER THE LAST YEAR THIS PARTICULAR INSTRUMENT HAS HAD SIGNIFICANT ISSUES WITH MISFIRES AND SCISSORING OF THE STAPLE. OVER 30% OF THE FIRES RESULT WITH NO CLIP BEING APPLIED. WHEN THEY ARE APPLIED THEY TEND TO BE LOOSE AND OR SCISSORED. PATIENT STATUS: NO PATIENT INJURY REPORTED. INTERVENTION: UNK.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: UNK. EVENT DESCRIPTION: COMPLAINTS (B)(4) NCL. COMPLAINTS (B)(4) CLIP SCISSORED. HOSPITAL: [INSTITUTION]. INFORMATION RECEIVED FROM [NAME] VIA EMAIL ON 14MAY2024: OVER THE LAST YEAR THIS PARTICULAR INSTRUMENT HAS HAD SIGNIFICANT ISSUES WITH MISFIRES AND SCISSORING OF THE STAPLE. OVER 30% OF THE FIRES RESULT WITH NO CLIP BEING APPLIED. WHEN THEY ARE APPLIED THEY TEND TO BE LOOSE AND OR SCISSORED. PATIENT STATUS: NO PATIENT INJURY REPORTED INTERVENTION: UNK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395261 CA500, EPIX UNIVERSAL CLIP APPLIER 3/BX CLIP, IMPLANTABLE FZP APPLIED MEDICAL RESOURCES CA500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown