BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS DEVICE

    MDR report key: 4890730 · Received July 1, 2015

    Report

    Report Number
    3010704463-2015-00001
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    May 7, 2015
    Report Date
    June 5, 2015
    Manufacturer
    ENDOAID LTD
    Product Code
    FED
    PMA / PMN Number
    K133359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS PREVIOUSLY REPORTED TO FDA ON 06/05/2015, VIA THE MEDWATCH VOLUNTARY REPORTING PROCESS (3010704463-2015-00001). AS THE DEVICE MANUFACTURER, ENDOAID UNDERSTANDS THAT ITS REPORT SHOULD HAVE BEEN SUBMITTED PER THE MANDATORY MEDICAL DEVICE REPORTING REQUIREMENTS. THEREFORE, THIS REPORT IS BEING RESUBMITTED TO FDA AGAIN FOLLOWING THE CORRECT PROCEDURES. ENDORINGS ADULT MODEL E101 WAS ASSEMBLED ON A PEDIATRIC SCOPE NOT ACCORDING TO IFU INSTRUCTIONS. ENDORINGS ADULT MODEL E101 FIT ON THE PEDIATRIC SCOPE WAS TOO LOOSE WHICH RESULTED IN ITS DETACHMENT FROM THE SCOPE DURING THE PROCEDURE. THE ENDORINGS WAS RETRIEVED EASILY, NO DAMAGE OR ADDITIONAL DISCOMFORT TO THE PT. PREVENTIVE ACTION: REPEATED IN-SERVICE IN THE FACILITY BY A PRODUCT SPECIALIST.

    Description of Event or Problem · 1

    THE ENDORINGS DEVICE IS INTENDED TO BE ATTACHED TO THE DISTAL END OF THE ENDOSCOPE TO FACILITATE ENDOSCOPIC THERAPY, TO BE USED FOR THE FOLLOWING: KEEPING THE SUITABLE DEPTH OF ENDOSCOPIC FIELD OF VIEW. THE USER REPORTED THE ENDORINGS DEVICE BECAME DETACHED FROM THE ENDOSCOPE NEAR THE SIGMOID COLON. THE PHYSICIAN RETRIEVED THE DEVICE WITH A RAPTOR GRASPING DEVICE. THERE WAS A DELAY IN PROCEDURE OF APPROXIMATELY 3-5 MINUTES FOR THE RETRIEVAL. THERE WAS NO HARM TO THE PT AS A RESULT OF THE DEVICE RETRIEVAL. THE USER ALSO REPORTED THE ENDORINGS DEVICE HAD A DETACHED FROM THE ENDOSCOPE BECAUSE THE WRONG SIZE DEVICE (TOO LARGE) HAD BEEN SELECTED FOR USE WITH THE ENDOSCOPE (FUJI MODEL #EC-530LS2). THERE WAS NO REPORT OF PRODUCT DEFECT OR MALFUNCTION. THE DEVICE WAS DISPOSED OF AFTER RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426313 ENDORINGS DEVICE ENDORINGS FED ENDOAID LTD E101 10100019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention