BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDORINGS DEVICES

    MDR report key: 4890731 · Received July 1, 2015

    Report

    Report Number
    3010704463-2015-00002
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ENDOAID LTD
    Product Code
    FED
    PMA / PMN Number
    K133359
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT CONTRAINDICATED FOR DEVICE USE AS DEFINED IN THE IFU. IT IS UNCLEAR IF PERFORATION OCCURRED DUE TO SCOPE TIP, SCOPE INSERTION TUBE, OR THE ENDORINGS DEVICE, WHICH IS A DISTAL ATTACHMENT ONTO THE COLONOSCOPE AND SEATS A FEW MM BEHIND THE SCOPE TIP. THE SIZE AND SHAPE OF THE PERFORATION IS UNK, AND THEREFORE IT IS NOT POSSIBLE TO ASSESS FROM THE WOUND WHAT CAUSED THE PERFORATION. IT IS UNCLEAR WHETHER THE PERFORATION OCCURRED DURING THE FIRST PASS WITH THE ENDORINGS OR DURING THE SECOND PASS WITHOUT THE ENDORINGS AS THE PERFORATION WAS NOT SEEN DURING FIRST PASS SCOPE WITHDRAWAL. NEVERTHELESS, PRECAUTIONS SHOULD BE TAKEN UNDER THE WORST-CASE SCENARIO THAT IT WAS INDUCED BY THE ENDORINGS.

    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 FACILITY REPORTED DISCOVERING SEVERE DIVERTICULAR DISEASE AND A VERY TIGHT/NARROW COLON DURING USE OF THE ENDORINGS DEVICE FOR A SCREENING COLONOSCOPY ON A FEMALE PT (AGE EARLY 60'S) WITH PREVIOUS HISTORY OF ABDOMINAL SURGERY. THE ENDOSCOPE WAS WITHDRAWN AND THE ENDORINGS DEVICE WAS REMOVED. THE ENDOSCOPE WAS THEN REINSERTED AND A PERFORATION WAS DETECTED. THE PT WAS HOSPITALIZED AND TREATED LAPAROSCOPICALLY, AND IS RECOVERING. INFO FOUND IN THE ENDORINGS INSTRUCTIONS FOR USE INCLUDES: "DO NOT USE THE DEVICE IN PTS WITH KNOWN STRICTURES OR OTHER CONDITIONS THAT MAY PRESENT WITH NARROWED COLONIC SEGMENTS", "THE ENDORINGS DEVICE SHOULD NOT BE USED IN CASES WITH ACUTE, SEVERE COLITIS OR WHERE THERE IS A KNOWN COLONIC STRICTURE." AS NOTED IN CLINICAL LITERATURE, PERFORATION IS A POTENTIAL COMPLICATIONS RELATED TO COLONOSCOPY WITH A BASELINE OCCURRENCE RATE OF .01% TO .03%. RISK FACTORS AND COMORBIDITIES WHICH INCREASE THE RATE OF PERFORATION INCLUDE DIVERTICULAR DISEASE, PREVIOUS INTRA-ABDOMINAL SURGERY, AGE, AND FEMALE GENDER. THE PHYSICIAN STATED THE SEVERE DIVERTICULAR CONDITION AND THE PRIOR HYSTERECTOMY WHICH RESULTED IN A TIGHT COLON WERE PRIMARY FACTORS IN THE OCCURRENCE OF PERFORATION, AND STATED THE PERFORATION WOULD HAVE OCCURRED WITHOUT USE OF THE ENDORINGS DEVICE. THE ACTUAL DEVICE WAS NOT RETURNED, HOWEVER, DEVICES FROM THE SAME LOT NUMBER ARE BEING SENT BACK TO THE MANUFACTURE FOR EVALUATION. AN UPDATED REPORT WILL BE SUBMITTED IF FURTHER INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426458 ENDORINGS DEVICES ENDORINGS FED ENDOAID LTD E101 10100020

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention