BEUDAMED
    FDA Adverse Event Other Summary report: N

    HARNESS, A-E GI ADAPTER

    MDR report key: 843816 · Received May 1, 2007

    Report

    Report Number
    2150060-2007-00004
    Event Type
    Other
    Date Received
    May 1, 2007
    Date of Event
    March 21, 2007
    Report Date
    April 30, 2007
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEM/DIVISION OF MINNTECH
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY CONTACT STATED THEY ORDERED PEDIATRIC COLONSCOPE CONNECTORS (HU0068) BUT RECEIVED (HU0069) INSTEAD. UPON RECEIPT OF THE CONNECTORS, THE PART NUMBER WAS VERIFIED. APPROXIMATELY 3-4 DAYS LATER, WHEN THE ENDOSCOPE SUPPORT SPECIALIST ARRIVED, IT WAS IMMEDIATELY DISCOVERED THAT THE WRONG CONNECTORS HAD BEEN IN USE AND SCOPES MAY HAVE BEEN INCORRECTLY REPROCESSED. SPECIALIST NOTICED LOWER CONNECTING "Y" TUBE WAS MISSING. FACILITY TEMPORARILY MOVED TO MANUAL REPROCESSING/CLEANING WITH AN ASMADIC CLEANING SOLUTION. NEW KIT WAS ORDERED AND RECEIVED CORRECTLY. CONNECTORS RETURNED TO MANUFACTURER FOR EVALUATION. VERIFIED HOOK-UP WAS LABELED INCORRECTLY. RISK IS MINIMAL BECAUSE SCOPE STILL EXPOSED TO DISINFECTANT, THE CHANNEL WOULD BE OPEN AS IT WAS SUBMERGED. INTERNAL INVESTIGATION HAS REVEALED THIS TO BE A SINGLE ISOLATED INCIDENT. NO OTHER PRODUCT WAS EFFECTED. ISSUED CORRECTIVE ACTION TO PREVENT RECURRENCE OF THIS ISSUE. NO PATIENT INJURIES TO REPORT AT THIS TIME.

    Description of Event or Problem · 1

    FACILITY REPORTS PEDIATRIC COLONSCOPE CONNECTORS RECEIVED WERE MIS-LABELED, THUS SCOPES MAY HAVE BEEN INCORRECTLY REPROCESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARNESS, A-E GI ADAPTER CONNECTORS/HOOK-UPS FEB MEDIVATORS REPROCESSING SYSTEM/DIVISION OF MINNTECH DSD-110-HU0068 186935

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other