BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INZII RETRIEVAL SYSTEM

    MDR report key: 24515666 · Received March 5, 2026

    Report

    Report Number
    2027111-2026-00416
    Event Type
    Malfunction
    Date Received
    March 5, 2026
    Date of Event
    January 27, 2026
    Report Date
    March 4, 2026
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915123406
    PMA / PMN Number
    K100959
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT IS NOT BEING RETURNED TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. EVENT DESCRIPTION: AI TRANSLATED: I WISH TO INFORM YOU OF A QUALITY DEFECT THAT OCCURRED ON (B)(6) 2026, CONCERNING THE FOLLOWING DEVICE: PRODUCT: RETRIEVAL BAG. REF: CD003. BATCH: 1558541. EXPIRY DATE: JUNE 22, 2028. DESCRIPTION OF THE INCIDENT: DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE BAG DEPLOYED AND CLOSED CORRECTLY, BUT ONCE THE SUTURE WAS REMOVED FROM THE ABDOMEN, THE BAG IMMEDIATELY CAME LOOSE INSIDE THE PATIENT. THIS PROBLEM HAS ALREADY OCCURRED TWICE. THIS RESULTS IN A LOSS OF TIME AND A RISK OF LOSING THE SURGICAL SPECIMEN. INTERVENTION: NI. PATIENT STATUS: NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579350 INZII RETRIEVAL SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD003 1558541 00607915123406

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown