BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OES CHOLEDOCHOFIBERSCOPE

    MDR report key: 1933126 · Received December 13, 2010

    Report

    Report Number
    8010047-2010-00248
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP
    Product Code
    FBN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY TO GATHER ADDITIONAL INFO REGARDING THIS REPORT. THE USER FACILITY REPORTED THAT THE SCOPE WAS NOT UTILIZED ON THE PT AFTER THE DAMAGE WAS NOTICED. THE PROCEDURE WAS SAID TO HAVE BEEN DELAYED FOR AN UNSPECIFIED PERIOD, AND AN OPEN PROCEDURE WAS REPORTEDLY PERFORMED ON THE PT. THERE WAS NO INFO PROVIDED AS TO WHY AN OPEN SURGERY WAS PERFORMED OR FURTHER INFO REGARDING THE STATUS OF THE PT. THE USER FACILITY REPORTED THAT THERE WAS PEELING AND CRUMBLING VISIBLE ON THE INSERTION TUBE APPROX 4 INCHES AND 9 INCHES FROM THE DISTAL END. THE PHYSICIAN ALLEGED THAT THIS PHENOMENON WAS DUE TO AN IMPROPER REPAIR OF THE DEVICE. THE DEVICE INSTRUMENT HISTORY INDICATES THE UNIT WAS SERVICED BY OLYMPUS IN (B)(6) 2010. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVAL, BUT THE FACILITY INDICATED THAT THEY ARE WILLING TO DO SO AND HAVE BEEN PROVIDED A SHIPPING CONTAINER. THE EXACT CAUSE OF THE REPORTED PHENOMENON WAS UNABLE TO BE DETERMINED AT THIS TIME. IF ADDITIONAL SIGNIFICANT INFO IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED. THE (B)(4) INSTRUCTION MANUAL STATES: "WARNING: BEFORE EACH CASE, PREPARE AND INSPECT THIS INSTRUMENT AS INSTRUCTED BELOW. INSPECT OTHER EQUIPMENT USED WITH THIS INSTRUMENT AS INSTRUCTED IN THEIR RESPECTIVE INSTRUCTION MANUALS. SHOULD THE SLIGHTEST IRREGULARITY BE SUSPECTED, DO NOT USE THE EQUIPMENT..." THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT, WHICH STATED: "PT UNDERWENT SURGERY FOR CHOLECYSTITIS WITH CHOLELITHIASIS. AFTER REMOVAL OF GALLBLADDER AND STONES, A CHOLEDOCHOSCOPE WAS ABOUT TO BE UTILIZED TO CHECK DUCT. PREPROCEDURE FUNCTION CHECK OF SCOPE DEMONSTRATED THE SHEATH COVERING CRUMBLING AND PEELING OFF IN 2 PLACES. ONE AREA 3" LONG AND SECOND AREA 5/8" LONG. THIS SHEATH HAD RECENTLY BEEN REPLACED BY OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OES CHOLEDOCHOFIBERSCOPE COLEDOCHOSCOPE FBN OLYMPUS MEDICAL SYSTEMS CORP CHF-P20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR