BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AB MEDICA CURVED SCISSOR AND INSERT

    MDR report key: 14801183 · Received June 23, 2022

    Report

    Report Number
    MW5110491
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 21, 2022
    Manufacturer
    AB MEDICA SAS
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE REQUALIFICATION OF OUR THERMOSEALING PROCESS SHOWED A NON CONFORMITY ON OUR SEALINGS. AFTER FURTHER INVESTIGATION, THE TYVEK BATCH USED IN THESES SEALINGS HAS BEEN FOUND NON CONFORMANT BECAUSE THE SEAL WIDTH IS SMALLER THAN EXPECTED. THE EVALUATION OF THE NON-CONFORMITY SHOWED THAT THIS BATCH HAS BEEN USED IN PRODUCT PACKAGING DISTRIBUTED IN THE US. THIS DEFECT IS NOT AFFECTING THE STERILE STATE OF THE PRODUCT SINCE THE INTEGRITY TESTING ACCORDING TO ASTM F 1929 HAS BEEN FOUND CONFORM. FOR THE FIRST TEST, 9 PRODUCTS WERE FOUND NON CONFORMANT BY THE LABORATORY RESCOLL FINDING THAT THE SEAL WIDTH WAS 3 TO 5.5MM ON THOSE 9 PRODUCTS WHEREAS IT IS REQUIRED AT LEAST 6 MM. THE SECOND TEST REALIZED IN THE SAME LABORATORY WAS CONFORM ON ALL 27 PRODUCTS TESTED DEMONSTRATING THAT THE PACKAGING REMAINS SEALED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267215 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST
    1267216 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST
    1267217 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST
    1267218 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST
    1267219 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST
    608918 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST
    608919 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST
    608920 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST
    608921 AB MEDICA CURVED SCISSOR AND INSERT LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ AB MEDICA SAS LIL-IP-2SC-20ST EK07210008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown