BEUDAMED
    FDA Adverse Event Summary report: N

    RAPICIDE HIGH LEVEL DISINFECTANT

    MDR report key: 4757593 · Received May 7, 2015

    Report

    Report Number
    2150060-2015-00013
    Date Received
    May 7, 2015
    Date of Event
    April 16, 2015
    Report Date
    May 6, 2015
    Manufacturer
    MEDIVATORS
    Product Code
    MED
    PMA / PMN Number
    K993042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN REPORTED A PATIENT THAT EXPERIENCED CHEMICAL COLITIS AFTER HAVING AN ENDOSCOPY PROCEDURE WITH A SCOPE THAT WAS REPROCESSED USING RAPICIDE HIGH LEVEL DISINFECTANT IN A MEDIVATORS CER-1 AUTOMATED ENDOSCOPE REPROCESSOR (AER). THE AER SEEMED TO BE FUNCTIONING PROPERLY AND THE FACILITY REQUESTED AN INSERVICE ON THE AER. A MEDIVATORS FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO CHECK THE PERFORMANCE OF THE AER AND IT WAS OPERATING ACCORDING TO SPECIFICATION. PATIENT CONDITION IS UNKNOWN AT THIS TIME. TO DATE, MEDIVATORS HAS NOT BEEN NOTIFIED OF ANY OTHER CHEMICAL COLITIS CASES. THIS COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH THE MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED A PATIENT THAT EXPERIENCED CHEMICAL COLITIS AFTER HAVING AN ENDOSCOPY PROCEDURE WITH A SCOPE THAT WAS REPROCESSED USING RAPICIDE HIGH LEVEL DISINFECTANT IN A MEDIVATORS CER-1 AUTOMATED ENDOSCOPE REPROCESSOR (AER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300157 RAPICIDE HIGH LEVEL DISINFECTANT HIGH LEVEL DISINFECTANT MED MEDIVATORS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other