BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELIMINATOR PET

    MDR report key: 3434108 · Received October 4, 2013

    Report

    Report Number
    3434108
    Event Type
    Malfunction
    Date Received
    October 4, 2013
    Date of Event
    September 25, 2013
    Report Date
    October 4, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD FEMALE WITH A DIAGNOSIS OF CROHN'S DISEASE AND ADENOMATEOUS COLONIC POLYPS WAS UNDERGOING A COLONOSCOPY FOR GENERALIZED ABDOMINAL DISTRESS AND FOLLOW-UP FOR CROHN'S AND PRIOR POLYPS. THE COLONOSCOPY ALSO INVOLVED SEVERAL BIOPSIES. THE PHYSICIAN, WITH ASSISTANCE OF AN RN, INTRODUCED A BALLOON DILATOR (CONMED ELIMINATOR PET BALLOON DILATOR - CATALOGUE # 000846) INTO A STRICTURED AREA AT THE ILIEO-COLONIC JUNCTION. THE BALLOON APPEARED TO BE UNDERINFLATED SO IT WAS WITHDRAWN. THE GASTROENTEROLOGIST MADE A SECOND ATTEMPT BUT THE INSTRUMENT WOULD NOT PASS. THE PHYSICIAN AND RN THEN NOTICED A WHITE FOREIGN BODY PROTRUDING FROM THE ILEUM. THIS WAS WITHDRAWN WITH A SNARE AND NOTED TO BE THE PLASTIC SAFETY TIP FROM THE BALLOON WHICH SHOULD NOT DETACH. ON EXAMINATION, THE BALLOON DILATOR WAS MISSING THE TIP, EXPOSING A SHARP PIECE OF WIRE. IT IS UNCLEAR WHEN THE TIP FELL OFF. THERE WAS NO INDICATION THAT THE MUCOSA WAS INJURED OR PUNCTURED. THE PATIENT WAS INFORMED OF THIS INCIDENT.======================MANUFACTURER RESPONSE FOR ELIMINATOR PYLORIC/ COLONIC 10 MM BALLOON DILATOR, ELIMINATOR PYLORIC/ COLONIC 10 MM BALLOON DILATOR (PER SITE REPORTER).======================WE HAVE NOT YET HEARD BACK FROM MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504506 ELIMINATOR PET DILATOR KNQ CONMED CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR