BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM

    MDR report key: 18055501 · Received November 2, 2023

    Report

    Report Number
    3006722112-2023-00211
    Event Type
    Injury
    Date Received
    November 2, 2023
    Date of Event
    October 8, 2023
    Report Date
    October 8, 2023
    Manufacturer
    APOLLO ENDOSURGERY, INC.
    Product Code
    OCW
    UDI-DI
    10811955020763
    PMA / PMN Number
    K201808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINED MEDWATCH SUBMITTED TO THE FDA ON 02NOV2023. A REVIEW OF THE DEVICE LABELING NOTES THE FOLLOWING: THE CURRENT X-TACK¿ ENDOSCOPIC HELIX TACKING SYSTEM INSTRUCTIONS FOR USE (IFU) ADDRESSED THE KNOWN AND POTENTIAL EVENTS OF PREMATURE SEPARATION OF TACK AS FOLLOWS: THE X-TACK¿ SYSTEM IS INTENDED FOR APPROXIMATION OF SOFT TISSUE IN MINIMALLY INVASIVE GASTROENTEROLOGY PROCEDURES (E.G. CLOSURE AND HEALING OF ESD/EMR SITES, AND CLOSING OF FISTULA, PERFORATION OR LEAKS). PRECAUTIONS: THE SYSTEM MAY ONLY BE USED IF PURCHASED FROM APOLLO ENDOSURGERY, INC. OR ONE OF ITS AUTHORIZED AGENTS. ADVANCE DEVICE CATHETER AND PUSH HELIX TACK AGAINST TISSUE. CAUTION: ENSURE THE HANDLE IS IN RESET POSITION PRIOR TO DRIVING HELIX TACK. NOTE: DO NOT RETRACT DEVICE CATHETER FROM THE WORKING CHANNEL WHILST A HELIX TACK IS INSTALLED; THIS COULD LEAD TO DEVICE DAMAGE OR INADVERTENT DETACHMENT. ADDITIONAL INFORMATION: THE INVESTIGATOR DETERMINED THAT A DEVICE HISTORY RECORD (DHR) REVIEW IS REQUIRED FOR THIS COMPLAINT DUE TO THE COMPLAINT BEING VIGILANCE OR MDR REPORTABLE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR REPORTING PURPOSES. THERE WERE NO OTHER COMPLAINTS IN THE APOLLO DATABASE AGAINST THIS LOT NUMBER AND THIS ALLEGATION, (B)(4). THE SUBJECT PRODUCT MET ALL SPECIFICATIONS AND REQUIREMENTS IN EFFECT AT THE TIME OF MANUFACTURE. DEVICE EVALUATION SUMMARY: ASSESSMENT OF THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT POSSIBLE, AND IT HAS NOT BEEN POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THIS EVENT. THE USER EFFECTS OF PREMATURE SEPARATION OF TACK, IRRITATION/INFLAMMATION, INFECTION, HSOPITALIZATION ARE KNOWN AND LABELED POSSIBLE ADVERSE EVENT.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED X-TACK DEVICE FAILUED POST PROCEDURE. PATIENT ADMITTED TO THE HOSPITAL TO REPAIR DEFECT LEAK AS WELL AS TREAT DEVELOPED MEDIASTINIS, SEPSIS, PLEURAL EFFUSION, PNEUMONIA AND ATELECTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927980 OVERSTITCH¿ ENDOSCOPIC SUTURE SYSTEM SUTURING SYSTEM OCW APOLLO ENDOSURGERY, INC. XTACK-160-H AF05213 10811955020763

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization