BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INZII RETRIEVAL SYSTEM

    MDR report key: 22032279 · Received May 15, 2025

    Report

    Report Number
    2027111-2025-00535
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 10, 2025
    Report Date
    November 7, 2025
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915117382
    PMA / PMN Number
    K060051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. VISUAL INSPECTION CONFIRMED THE COMPLAINANT¿S EXPERIENCE OF BEAD DETACHMENT, AS THE BEAD WAS DETACHED FROM THE SPECIMEN BAG. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND RELATED PRODUCTS AND IS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT BASED ON THE EVALUATION OF THE RETURNED UNIT. APPLIED MEDICAL HAS PERFORMED A HISTORICAL TREND ANALYSIS AND REVIEW OF PRODUCTION RECORDS AND NO SYSTEMIC PATTERNS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT HAS 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: NA. EVENT DESCRIPTION: COMPLAINT 1 OF 3: 2025-000990, COMPLAINT 2 OF 3: 2025-001076, COMPLAINT 3 OF 3: 2025-001077. DURING A CHOLECISTECTOMY DURING THE MOMENT TO CLOSE THE ENDOBAG WITH THE SPECIMEN INSIDE. THE DOCTOR START TO INSERT THE INZII TO PUT INSIDE THE CHOLECYST SO HE STARTED TO PUSH THE PISTON TO GET THE BAG, HE INSERT THE SPECIMEN, WHEN THEY WERE STARTING TO PULL THE PISTON UP AND TAKE OFF THE GUIDE WIRE THE BAG STUCK IN THE TUBE HOLE. THE DOCTOR TRY SEVERAL TIME TO TAKE DOWN THE BAG AND SO USING STRENGTH THE BAG GET DOWN BUT THE PROBLEM IS THE ROUND GREEN GUIDE WIRE ON THE TOP THAT IS NOT MORE FIXED IN THE WIRE. THE PATIENT IS OK, BUT THE PROBLEM IS THE ROUND GREEN LITTLE BALL THAT ON THE WIRE GUIDE. THIS CAN FALL INTO THE ABDOMEN. THEY FORCED THE BAG FROM THE METAL TUBE AND IN SOME WAYS ( A LOT) THEY FINALLY CLOSED THE BAG AND TAKE IT AWAY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16APR25: I HAVE TWO STERILE SAMPLE OPENED FOR ME FROM THE 2 DIFFERENT BOXES TO VERIFY THE PROBLEM, THE THIRD SAMPLE ( THAT THEY USED IN THE OR) THEY GIVE ME ONLY THE PAPER REF BECAUSE THE SAMPLE WAS THREW IT AWAY AND THEY SHOW ME THIS ONE SAMPLE I MEAN (WHAT I CAN SEE IS THE PAPER) BELONG TO ANOTHER BOX. SO TOTALLY THEY HAVE 3 BOXES WITH THE SAME LOT. I HAVE 2 STERILE SAMPLE OPENED IN FRON OF ME FROM 2 OF THESE 3 BOXES TO SHOW ME THE MALFUNCTION OF THEM. THE THIRD BOX I HAVE ONLY THE PAPER WHICH HAVE THE SAME LOT AND CAUSED THE PROBLEM IN THE OPERATING ROOM. SO, ALL THE 3 DEVICES WERE FAULTY, THEY WERE STERILE SAMPLE (NOT ANYMORE WHEN THEY OPEN IN FRONT OF ME). TWO OF THESE WERE OPEN TO ME AS INSPECTION AND ONE WAS DURING A SURGERY/TREATMENT, (THE ONE THAT I PHYSICALLY DON¿T HAVE ONLY HAVE THE PAPER REF) LOT NUMBER IS THE SAME OF THESE 3 CD001:1532774. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18APR25: YES, THE BEAD DETACHED. THE SNAP RING DIDN'T DETACH. INTERVENTION: NA. PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: NA EVENT DESCRIPTION: COMPLAINT 1 OF 3: (B)(4), COMPLAINT 2 OF 3: (B)(4), COMPLAINT 3 OF 3: (B)(4). DURING A CHOLECISTECTOMY DURING THE MOMENT TO CLOSE THE ENDOBAG WITH THE SPECIMEN INSIDE. THE DOCTOR START TO INSERT THE INZII TO PUT INSIDE THE CHOLECYST SO HE STARTED TO PUSH THE PISTON TO GET THE BAG, HE INSERT THE SPECIMEN, WHEN THEY WERE STARTING TO PULL THE PISTON UP AND TAKE OFF THE GUIDE WIRE THE BAG STUCK IN THE TUBE HOLE. THE DOCTOR TRY SEVERAL TIME TO TAKE DOWN THE BAG AND SO USING STRENGTH THE BAG GET DOWN BUT THE PROBLEM IS THE ROUND GREEN GUIDE WIRE ON THE TOP THAT IS NOT MORE FIXED IN THE WIRE. THE PATIENT IS OK, BUT THE PROBLEM IS THE ROUND GREEN LITTLE BALL THAT ON THE WIRE GUIDE. THIS CAN FALL INTO THE ABDOMEN. THEY FORCED THE BAG FROM THE METAL TUBE AND IN SOME WAYS ( A LOT) THEY FINALLY CLOSETHE BAG AND TAKE IT AWAY. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 16APR25: I HAVE TWO STERILE SAMPLE OPENED FOR ME FROM THE 2 DIFFERENT BOXES TO VERIFY THE PROBLEM, THE THIRD SAMPLE ( THAT THEY USED IN THE OR) THEY GIVE ME ONLY THE PAPER REF BECAUSE THE SAMPLE WAS THREW IT AWAY AND THEY SHOW ME THIS ONE SAMPLE I MEAN ( WHAT I CAN SEE IS THE PAPER) BELONG TO ANOTHER BOX. SO TOTALLY THEY HAVE 3 BOXES WITH THE SAME LOT. I HAVE 2 STERILE SAMPLE OPENED IN FRONT OF ME FROM 2 OF THESE 3 BOXES TO SHOW ME THE MALFUNCTION OF THEM. THE THIRD BOX I HAVE ONLY THE PAPER WHICH HAVE THE SAME LOT AND CAUSED THE PROBLEM IN THE OPERATING ROOM. SO, ALL THE 3 DEVICES WERE FAULTY, THEY WERE STERILE SAMPLE (NOT ANYMORE WHEN THEY OPEN IN FRONT OF ME) TWO OF THESE WERE OPEN TO ME AS INSPECTION AND ONE WAS DURING A SURGERY/TREATMENT, (THE ONE THAT I PHYSICALLY DON¿T HAVE ONLY HAVE THE PAPER REF) LOT NUMBER IS THE SAME OF THESE 3 CD001 :1532774. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 18APR25: YES, THE BEAD DETACHED. THE SNAP RING DIDN'T DETACH. INTERVENTION: NA PATIENT STATUS: NA (NO PATIENT INVOLVEMENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215933 INZII RETRIEVAL SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ APPLIED MEDICAL RESOURCES CD001 1532774 00607915117382

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown