BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELPOINT PATH

    MDR report key: 3551905 · Received January 3, 2014

    Report

    Report Number
    2027111-2013-00567
    Event Type
    Malfunction
    Date Received
    January 3, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 23, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    HET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    MUCOSAE EXCISSION FOR A PRECEDENT POLYP RESULTED A T1 AFTER HYSTOLOGIC EXAM - "DURING EXCANGE OF CURVED INSTRUMENTS, THE THE TRANSPARENT PART OF UNIVERSAL SEAL OF A TROCAR DETACHED AND FELL IN THE PATIENT, THEY NEED TO RECOVER WITH A GRASPER. THEY TRIED TO REINSERT IT BUT WITH NO SUCCESS AND THE TROCAR HAD AIR LEAKAGE. TROCAR WERE OPTIC WAS INSERTED, ESCAPED FROM GEL MORE THAN ONE TIME (IT WAS INSERTED AGAIN AND AGAIN WITH OBTURATOR). THEY WORKED WITH OPTIC SHAFT DIRECTLY INSERTED IN THE GEL."PATIENT STATUS - "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3553 GELPOINT PATH TRANSANAL ACESS PLATFORM, CODE:FER HET APPLIED MEDICAL CNO11 1207470

    Patients

    Seq Age Sex Outcome Treatment
    1