BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE PLUS

    MDR report key: 7421179 · Received April 11, 2018

    Report

    Report Number
    2150060-2018-00028
    Event Type
    Injury
    Date Received
    April 11, 2018
    Date of Event
    March 13, 2018
    Report Date
    April 11, 2018
    Manufacturer
    MEDIVATORS
    Product Code
    FEB
    UDI-DI
    00677964044755
    PMA / PMN Number
    K082988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS RECEIVED INFORMATION FROM (B)(6) FACILITIES WHICH ARE EXPERIENCING A WHITE RESIDUE BEING LEFT ON OLYMPUS ENDOSCOPES AFTER REPROCESSING IN ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSORS AND OTHER AERS. IT WAS REPORTED THAT THE FACILITY TEMPORARILY SUSPENDED ALL ELECTIVE GI PROCEDURES TO INVESTIGATE CAUSE AND IDENTIFY THE RESIDUE. (B)(6) REPORTED THAT NUMEROUS TESTS WERE PERFORMED OF THE RESIDUAL MATERIAL BY THIRD PARTY LABS, IDENTIFYING THE RESIDUE AS A SILICONE-BASED COMPOUND. MEDIVATORS REQUESTED A COPY OF THE TEST REPORTS PERFORMED BY EACH LAB. MEDIVATORS PERFORMED INTERNAL INVESTIGATIVE TESTING OF THE RESIDUE FROM ENDOSCOPES PROVIDED BY (B)(6). MEDIVATORS TESTING RESULTS IDENTIFIED THE RESIDUE AS POLY BUTYL METHACRYLATE WHICH IS A CHEMICAL COMMONLY USED AS THE ADHESIVE COMPOUND ON THE BACK OF TAPE, LABELS AND STICKERS. MEDIVATORS TESTING CONFIRMED THE RESIDUE IS NOT A SILICONE-BASED COMPOUND. IT WAS NOTED THAT EVEN WHEN THE AERS WERE REMOVED FROM THE HIGH LEVEL DISINFECTION (HLD) PROCESS AND REPLACED BY MANUAL HLD, THE RESIDUAL WAS STILL FOUND. UPON REVIEW OF THE DATA, MEDIVATORS AND THR STAFF AGREED THAT THE SOURCE OF THE RESIDUAL WAS NOT CAUSED BY THE AERS OR ANY OTHER MEDIVATORS PRODUCT. THR REPORTED THAT THEY ARE INSPECTING ALL ENDOSCOPES AFTER REPROCESSING AND REMOVING ANY REMAINING RESIDUAL USING ISOPROPYL ALCOHOL PRIOR TO USING FOR PROCEDURES. AS OF 3/22/2018, THR SENT A NOTIFICATION TO ITS STAFF/PHYSICIANS THAT THEY WERE RESUMING ALL ELECTIVE PATIENT PROCEDURES. MEDIVATORS REQUESTED A COPY OF THE NOTIFICATION SENT BY THR TO ITS PHYSICIANS COMMUNICATING THEY COULD RESUME ELECTIVE ENDOSCOPY PROCEDURES AND REPROCESSING OF ENDOSCOPES WITHIN THE THR FACILITIES. TO DATE, THERE HAVE BEEN NO REPORTS OF PATIENT HARM. MEDIVATORS REMAINS IN CONTACT WITH THR. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN MEDIVATORS COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    MEDIVATORS RECEIVED INFORMATION FROM (B)(6) FACILITIES WHICH ARE EXPERIENCING A WHITE RESIDUE BEING LEFT ON OLYMPUS ENDOSCOPES AFTER REPROCESSING IN ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSORS AND OTHER AERS. IT WAS REPORTED THAT THE FACILITY TEMPORARILY SUSPENDED ALL ELECTIVE GI PROCEDURES ACROSS ALL OF THEIR FACILITIES. TO DATE, THERE HAVE BEEN NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266019 ADVANTAGE PLUS AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS 00677964044755

    Patients

    Seq Age Sex Outcome Treatment
    1 Other