BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    PORT CLOSOR

    MDR report key: 17583123 · Received August 21, 2023

    Report

    Report Number
    3010437008-2023-00001
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    July 3, 2016
    Report Date
    June 19, 2023
    Manufacturer
    ADVANCED MEDICAL DESIGN CO., LTD.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WHICH CAUSED THE COMPLAINT WAS MANUFACTURED ON 2016.1.11 (LOT NO.: 1529654). THE SELF-INSPECTION RECORD AND THE IN-PROCESS-QUALITY-CONTROL (IPQC) RECORD WERE REVIEWED AND THERE WERE NO DEVIATIONS OBSERVED. SINCE THERE IS NO FURTHER INFORMATION FOR THE ISSUE FROM THE HOSPITAL OR THE SUPPLIER (E.G. WHEN AND WHERE DID THE ISSUE HAPPEN?), THE MECHANISM AND STRUCTURE OF PORT CLOSOR WERE ANALYZED TO ESTIMATE THE POTENTIAL FAILURE SITUATION. IT IS PRESUMED THAT THE BROKEN SITE WAS ON THE CONJUNCTION OF CANNULA AND PLASTIC PART. IF THE BROKEN SITE DID NOT HAPPEN ON THE LOCATION WE NOTED ABOVE, PORT CLOSOR WOULD BE DIVIDED INTO MORE THAN 2 PIECES. THE ASSEMBLY PROCESS OF THE CANNULA AND PLASTIC PART WOULD FOLLOW THE WORK INSTRUCTION (MP-P38) WHICH CONTROLS THE METHOD OF THE ASSEMBLY PROCESS. HOWEVER, THE PROCESS WAS A MANUAL PRODUCTION, THERE WAS A POTENTIAL RISK THAT THE GEL MAY NOT BE ENOUGH TO COVER ALL THE OUTER SURFACE OF THE CANNULA AND THE PLASTIC PART. CORRECTED DATA THE FULL SELF-INSPECTION FOR THE ASSEMBLY PARTS WILL BE ADDED INTO THE MANUFACTURING PROCESS BY PULLING THE 2 PARTS NAMED "CANNULA" AND "PLASTIC PART" BY HAND, AFTER FINISHING THE ASSEMBLY PRODUCTION. IF THERE IS NO SEPARATED PHENOMENON OBSERVED, THE ASSEMBLY PARTS WILL PROCEED TO THE NEXT PROCESS. OTHERWISE, THE ASSEMBLY PARTS WILL BE SCRAPPED.

    Description of Event or Problem · 0

    LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. DOCTOR USED LAPAROSCOPIC CLOSURE. PORT CLOSOR WHILE DOCTOR WAS USING DEVICE, PORT CLOSOR WAS BROKEN AND DIVIDED 2 PIECES, NO INJURY TO PATIENT AND NOTHING LEFT IN THE ABDOMEN. ALL NEEDS MET. NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1762523 PORT CLOSOR SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM ADVANCED MEDICAL DESIGN CO., LTD. PC-120 1529654

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown Other