BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCALPEL HOLDER RED STERILE

    MDR report key: 19626012 · Received June 27, 2024

    Report

    Report Number
    3002750084-2024-00027
    Event Type
    Malfunction
    Date Received
    June 27, 2024
    Report Date
    July 26, 2024
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    FSM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEALING ISSUES. THE ACTUAL DEVICE WAS NOT AVAILABLE FOR EVALUATION. PICTURES OF THE DEVICE AND THE CONCERN WERE PROVIDED FOR REVIEW. THE MANUFACTURING LOT NUMBER WAS ALSO PROVIDED FOR REVIEW. BASED ON REVIEW OF THE PICTURES, THE SCALPEL TRAY IN THE POUCH CONTAINED PART OF THE TYVEK SPLICE THAT WAS MISSED DURING ASPEN'S PRODUCTION RUN. WHEN ASPEN PERFORMS A SPLICE THERE IS A RED SECTION OF TYVEK BUT BECAUSE THE LABEL FACES UP TO THE OPERATOR THE RED SPLICE ON THE FILM SIDE OF THE POUCH GOES UNDETECTED SINCE IT FACES DOWNWARD. AWARENESS TRAINING WAS PERFORMED. IN ADDITION, WE ARE LOOKING INTO LONG TERM SOLUTIONS TO MINIMIZE OR ELIMINATE THIS TYPE OF CONCERN IN THE FUTURE. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM THE DISTRIBUTOR INDICATING THAT PRODUCT WAS FOUND WITH SEALING ISSUES. THE ACTUAL DEVICE IS AVAILABLE FOR EVALUATION. THE MANUFACTURING LOT NUMBER WAS PROVIDED FOR REVIEW. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM OUR DISTRIBUTOR INDICATING THAT A PRODUCT WAS DISCOVERED WITH SEALING ISSUES. NO SERIOUS INJURY OR DEATH WAS REPORTED. THIS IS ENTERED IN OUR COMPLAINT SYSTEM AS (B)(4).

    Description of Event or Problem · 0

    ASPEN SURGICAL RECEIVED A REPORT FROM OUR DISTRIBUTOR INDICATING THAT A PRODUCT WAS DISCOVERED WITH SEALING ISSUES. NO SERIOUS INJURY OR DEATH WAS REPORTED. THIS IS ENTERED IN OUR COMPLAINT SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479809 SCALPEL HOLDER RED STERILE SCALPEL HOLDER FSM ASPEN SURGICAL PRODUCTS, INC. ST-100 376678

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown