BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 22115650 · Received May 30, 2025

    Report

    Report Number
    2027111-2025-00560
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Report Date
    September 29, 2025
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT IS BEING RETURNED FOR EVALUATION AND NO LOT NUMBER HAS BEEN PROVIDED TO APPLIED MEDICAL. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION.

    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. BASED ON THE DESCRIPTION OF THE EVENT AND SIMILAR EVENTS, IT IS LIKELY THAT THE DISLODGED SHIELD AND FRAGMENTED SEAL COMPONENTS WERE CAUSED BY AN ASYMMETRICAL INSTRUMENT THAT WAS INSERTED IN A NON-AXIAL MANNER SUCH AS THE TISSUE COLLECTION BAG. APPLIED MEDICAL¿S INSTRUCTIONS FOR USE (IFU) STATES THAT, "EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS, SUCH AS 'J' HOOKS AND CLIP APPLIERS. ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL TO PREVENT TEARING." APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO TRENDS WERE IDENTIFIED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY EVENT DESCRIPTION: RECEIVED AN EMAIL FROM NCA WITH THE FOLLOWING STATING: THIS IS A FOLLOW-UP REGARDING A YELLOW CARD REPORT SUBMITTED TO THE MHRA ON 29 AUGUST 2024, CONCERNING A POTENTIAL MALFUNCTION OF YOUR 11X100MM FIRST ENTRY POINT PORT (BATCH 151369). DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TISSUE COLLECTION BAG WAS INTRODUCED THROUGH THE 11MM PORT WITHOUT INITIAL ISSUE; HOWEVER, PART OF THE INNER VALVE OF THE PORT WAS INADVERTENTLY PUSHED INTO THE PATIENT¿S ABDOMINAL CAVITY ALONG WITH THE BAG. TWO PLASTIC FRAGMENTS WERE SUCCESSFULLY RETRIEVED INTRAOPERATIVELY, AND A SECOND PORT OF THE SAME MODEL WAS OPENED TO CONFIRM THAT ALL PARTS WERE ACCOUNTED FOR. THE SURGICAL TEAM CONCLUDED THAT NO FURTHER FRAGMENTS REMAINED INSIDE THE PATIENT. LOT NUMBER IS MISSING A NUMBER. INTERVENTION: SECOND PORT OF THE SAME MODEL WAS USED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: RECEIVED AN EMAIL FROM NCA WITH THE FOLLOWING STATING: THIS IS A FOLLOW-UP REGARDING A YELLOW CARD REPORT SUBMITTED TO THE MHRA ON 29 AUGUST 2024, CONCERNING A POTENTIAL MALFUNCTION OF YOUR 11X100MM FIRST ENTRY POINT PORT (BATCH 151369). DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE TISSUE COLLECTION BAG WAS INTRODUCED THROUGH THE 11MM PORT WITHOUT INITIAL ISSUE; HOWEVER, PART OF THE INNER VALVE OF THE PORT WAS INADVERTENTLY PUSHED INTO THE PATIENT¿S ABDOMINAL CAVITY ALONG WITH THE BAG. TWO PLASTIC FRAGMENTS WERE SUCCESSFULLY RETRIEVED INTRAOPERATIVELY, AND A SECOND PORT OF THE SAME MODEL WAS OPENED TO CONFIRM THAT ALL PARTS WERE ACCOUNTED FOR. THE SURGICAL TEAM CONCLUDED THAT NO FURTHER FRAGMENTS REMAINED INSIDE THE PATIENT. LOT NUMBER IS MISSING A NUMBER. INTERVENTION: SECOND PORT OF THE SAME MODEL WAS USED. PATIENT STATUS: NO PATIENT INJURY OR ILLNESS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845104 UNK LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown TISSUE COLLECTION BAG