BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS COLONOSCOPE

    MDR report key: 415320 · Received August 28, 2002

    Report

    Report Number
    415320
    Event Type
    Malfunction
    Date Received
    August 28, 2002
    Date of Event
    August 19, 2002
    Report Date
    August 28, 2002
    Manufacturer
    OLYMPUS (UNKNOWN ADDRESS)/ALLEGIANCE HEALTH CARE
    Product Code
    FDF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM MFR 12/06/02: THE ALLEGIANCE FACILITY THAT RECEIVED THE DEVICE FOR REPAIR IS NOT THE MFR OR A REPROCESSOR OF THE DEVICE. THEREFORE, ALLEGIANCE HEALTHCARE DID NOT SUBMIT THE MEDICAL DEVICE REPORT FOR THIS DEVICE. THE DEVICE IS MANUFACTURED BY OLYMPUS CORPORATION. NOTIFICATION OF THE INCIDENT REFERENCED IN THE REPORT WAS FORWARDED TO OLYMPUS CORP BY ALLEGIANCE ON AUGUST 28, 2002. AS ALLEGIANCE IS NOT THE MFR, THIS RESPONSE CAN ONLY ADDRESS THE REPAIR PERFORMED ON THE DEVICE AT THE ALLEGIANCE ENDOSCOPIC REPAIR CENTER. THE OLYMPUS COLONSCOPE, CFQ 160L WAS RECEIVED FOR REPAIR ON JULY 17, 2002. THE CUSTOMER STATED THAT THE DEVICE WOULD NOT ANGULATE UP OR DOWN AND REQUESTED REPAIR. THE DEVICE WAS REPAIRED AND INSPECTED PRIOR TO RELEASE TO THE CUSTROMER OWNER OF THE DEVICE. THE DEVICE WAS RECEIVED FOR A SECOND REPAIR ON AUGUST 19, 2002. THE CUSTOMER STATED THAT THE COLONOSCOPE HAD BEEN USED IN 21 PROCEDURES SINCE THE ORIGINAL REPAIR. THE DEVICE WAS AGAIN REPAIRED, INSPECTED AND RELEASED TO THE CUSTOMER OWNER OF THE DEVICE. A REPAIR ANALYSIS WAS DONE TO REVIEW THE ORIGINAL MATERIALS AND PROCESSES INVOLVED IN THE REPAIR OF THE DEVICE. NO NONCONFORMITIES WERE IDENTIFIED. BASED ON THE REVIEW OF THE REPAIR, AND THE REPAIR HISTORY OF THIS DEVICE, IT APPEARS THAT THE SEPARATION AT THE BENDING SECTION AND INSERTION TUBE IS AN UNUSUAL OCCURRENCE. WHILE THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED, CONTRIBUTING FACTORS TO THE FAILURE MAY BE TRAUMA TO THE INSTRUMENT WHILE IN USE. AN EVALUATION OF MFR'S REPAIR PROCESSES WAS CONDUCTED TO DETERMINE IF THE FAILURE WAS ATTRIBUTABLE TO THE REPAIR PROCESS. FORTY-ONE INSERTION TUBES WERE REPLACED FROM MAY 1, 2002 TO AUGUST 31, 2002, USING THE SAME PROCESSES AND ADHESIVES WITHOUT SUBSEQUENTLY FAILURE. SEVEN OF THE FORTY-ONE INSERTION TUBES WERE REPLACED ON OLYMPUS CFQ160L MODEL. THE OPERATIONS MGR AND DIRECTOR OF OPERATIONS WITNESSED THE NEXT INSERTION TUBE REPLACEMENT BY THIS TECHNICIAN AND VERIFIED THAT ALL STEPS WERE PERFORMED CORRECTLY. SINCE THE REPORT WAS NOT SUBMITTED BY ALLEGIANCE, ALLEGIANCE DID NOT FORMULATE THE CONCLUSION CODE IN THE REPORT. THE DEVICE IS MANUFACTURED BY OLYMPUS CORP. THEREFORE, CO'S INVESTIGATION DID NOT IDENTIFY THE SOURCE OF THE FAILURE OF THE DEVICE. A REVIEW OF CO'S REPAIR HISTORY DOES NOT INDICATE AN ADVERSE TREND FOR THIS TYPE OF REPAIR FAILURE. ADDITIONALLY, THIS INCIDENT REPORT WAS FORWARDED TO THE ORIGINAL MFR, OLYMPUS AMERICA, INC WITH NOTIFICATION TO THE CUSTOMER OF THE FORWARDING OF THIS INFO.

    Description of Event or Problem · 1

    COLONSCOPE PROTECTIVE SHEATH BROKEN THE ENTIRE CIRCUMSTANCE OF THE SCOPE AT DISTAL END FOLLOWING PROCEDURE. SCOPE WAS "SNAGGING" ON MUCOSAL TISSUE AS IT WAS BEING WITHDRAWN, SHEATH WIDELY SEPARATED AND IT IS UNKNOWN WHEN THE SEPARATION OCCURRED, WHETHER LESSER (NOT VISIBLE TO THE NAKED EYE) PERFORATIONS IN THE SHEATH EXISTED PRIOR TO THE SEPARATION. THE SCOPE HAD BEEN RECENTLY REPAIRED, THE SHEATH REPLACED, AND IT HAD BEEN USED ON 21 PTS PRIOR TO SEPARATION. SO CONCERN RELATES TO THE TRANSMISSION OF BLOOD-BORNE PATHOGENS BETWEEN OR AMONG THE PTS ON WHOM THE SCOPE HAD BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS COLONOSCOPE ENDOSCOPIC COLONOSCOPE FDF OLYMPUS (UNKNOWN ADDRESS)/ALLEGIANCE HEALTH CARE CF Q160L *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other