BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1001190 · Received February 22, 2008

    Report

    Report Number
    8010047-2008-00030
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Report Date
    February 1, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR INVESTIGATION. THE INSTRUMENT CHANNEL WAS EXAMINED, AND SCRAPE AND TEAR MARKS WERE FOUND AT THE BENDING SECTION INSIDE OF THE INSTRUMENT CHANNEL, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION FOUND NON-OLYMPUS REPAIRS AND PARTS ON THE DEVICE. THE CAUSE OF THE USER'S EXPERIENCE WAS ATTRIBUTED TO PHYSICAL DAMAGE AND INSUFFICIENT CLEANING. FURTHERMORE, THE USE OF A THIRD-PARTY SERVICE PROVIDER CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE REPORTED EVENT. ACCORDING TO THE DEVICE INSTRUCTION MANUAL, THIS DEVICE IS TO BE REPAIRED BY OLYMPUS TECHNICIANS ONLY, AS OLYMPUS IS NOT LIABLE FOR ANY INJURY OR DAMAGE WHICH OCCURS AS A RESULT OF REPAIRS ATTEMPTED BY NON-OLYMPUS PERSONNEL. AN OLYMPUS ENDOSCOPE SUPPORT SPECIALIST HAS BEEN DISPATCHED TO INVESTIGATE THIS MATTER FURTHER AND TO CONDUCT AN IN-SERVICE TRAINING FOR THE FACILITY STAFF ON HOW TO PROPERLY CLEAN AND HANDLE THE DEVICE. IF SIGNIFICANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE PROVIDED. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A THERAPEUTIC GASTROSCOPY, WHILE A NON-OLYMPUS STENT WAS BEING REMOVED FROM THE PATIENT, THE STENT BROKE INTO PIECES AND PORTIONS OF THE STENT FELL INSIDE OF THE PATIENT. THE USERS REPORTEDLY UTILIZED FORCEPS TO REMOVE ALL OF THE DETACHED PIECES OF THE STENT. THE ENDOSCOPE WAS THEN CLEANED FOLLOWING THE PROCEDURE. HOWEVER, DURING THE NEXT THERAPEUTIC GASTROSCOPY, WIRES WHICH WERE BELIEVED TO BE PORTIONS OF THE STENT FROM THE PRIOR PROCEDURE FELL OUT OF THE ENDOSCOPE. THE USERS THEORIZED THAT THE WIRES THAT FELL INSIDE OF THE SECOND PATIENT MAY HAVE COME FROM THE BROKEN STENT FROM THE PREVIOUS PROCEDURE, WHICH UNKNOWINGLY GOT LODGED INSIDE THE INSTRUMENT CHANNEL OF THE DEVICE. THE USER FACILITY REPORTED THAT ALL OF THE PIECES THAT FELL INTO THE SECOND PATIENT WERE REMOVED WITH FORCEPS. THE USER FACILITY SUBSEQUENTLY SENT THE DEVICE TO A THIRD PARTY SERVICE PROVIDER, WHICH REPORTEDLY CLAIMED TO HAVE REPLACED THE ENDOSCOPE INSTRUMENT CHANNEL. HOWEVER, UPON USE OF THE DEVICE FOLLOWING THIRD-PARTY SERVICE, USERS REPORTED WIRES COMING OUT OF THE ENDOSCOPE AGAIN AND FALLING INTO A THIRD PATIENT. AGAIN, ALL OF THE PIECES WERE REMOVED FROM THE THIRD PATIENT WITH FORCEPS. ALL THREE PROCEDURES WERE COMPLETED WITH THE SAME DEVICE AND THERE WERE NO PATIENT INJURIES. MULTIPLE ATTEMPTS HAVE BEEN MADE BY PHONE AND IN WRITING TO OBTAIN ADDITIONAL DETAILED INFORMATION FROM THE USER FACILITY, BUT ADDITIONAL INFORMATION HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORPORATION GIF-Q180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK