BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFEGUIDE

    MDR report key: 5782047 · Received July 11, 2016

    Report

    Report Number
    2183446-2016-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    May 13, 2016
    Report Date
    May 23, 2016
    Manufacturer
    MEDOVATIONS INC.
    Product Code
    KNQ
    PMA / PMN Number
    K924646
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER COMPLAINT INITIALLY RECEIVED IN THE FORM OF A MEDWATCH REPORT, RECEIVED BY MEDOVATIONS ON 6-6-2016. MEDOVATIONS REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER FOUR (4) TIMES IN THE PERIOD FROM 6-9-2016 TO 7-1-2016 BUT RECEIVED NO RESPONSE FROM THE CUSTOMER. MEDOVATIONS COULD NOT CONDUCT A COMPLETE INVESTIGATION WITHOUT THIS INFORMATION FROM THE CUSTOMER. HOWEVER, MEDOVATIONS DID REVIEW THE DEVICE HISTORY RECORD AND THE DEVICE MARKET HISTORY. THE DESIGN HISTORY RECORD SHOWED ALL DEVICES WERE MANUFACTURED TO THE APPROPRIATE SPECIFICATION. THIS DEVICE HAS BEEN ON THE MARKET SINCE 1998 AND THIS CUSTOMER HAS BEEN PURCHASING THIS DEVICE FROM MEDOVATIONS SINCE 2000. THERE HAVE BEEN NO PREVIOUS COMPLAINTS OF THIS TYPE OF EVENT OCCURRING. THIS EVENT APPEARS TO HAVE BEEN CAUSED BY MULTIPLE USER FAILURES. THE CAP IS A PROTECTOR FOR SHIPPING AND TYPICALLY REMOVED BEFORE BEING BROUGHT INTO THE PROCEDURE ROOM. THE USER DROPPED THE CAP IN THE LUBRICANT CONTAINER AND THEN DID NOT NOTICE WHEN IT WAS APPLIED TO THE ENDOSCOPE. THESE ARE COMPOUNDED USER ERRORS THAT HAVE NEVER BEEN REPORTED BEFORE. AT THIS TIME, MEDOVATIONS HAS DETERMINED THAT THERE ARE NO NEW SAFETY OR EFFICACY ISSUES AS A RESULT OF THIS EVENT AND THEREFORE, WILL BE TAKING NO FURTHER ACTION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    EVENT DESC: THE COVERING ON THE END OF THE GUIDEWIRE WAS REMOVED. THE SCRUB TECH THOUGHT HE PUT IT ON THE BACK TABLE. IT APPARENTLY FELL INTO A CONTAINER THAT HAD LUBRICANT IN IT AND WAS USED TO LUBRICATE THEN ENDOSCOPE. THE CAP, WHICH IS CLEAR IN COLOR AS IS THE LUBRICANT, WAS RUBBED ONTO THE ENDOSCOPE AND PLACED IN THE PATIENT. IT WOULD BE SAFER IF THE CAP WAS A BRIGHT COLOR, SO THE TEAM CAN SEE IT MORE EASILY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ENDOSCOPY WITH ESOPHAGEAL DILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435971 SAFEGUIDE DILATOR, ESOPHAGEAL, GUIDEWIRE KNQ MEDOVATIONS INC. 1214-02 217116

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR