BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS

    MDR report key: 415247 · Received September 4, 2002

    Report

    Report Number
    MW1026066
    Event Type
    Injury
    Date Received
    September 4, 2002
    Date of Event
    August 6, 2002
    Report Date
    August 28, 2002
    Manufacturer
    OLYMPUS
    Product Code
    FDF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    BOWEL PERFORATION DURING COLONOSCOPY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 12/06/02: THE DEVICE IN QUESTION WAS INITIALLY RETURNED TO OLYMPUS AMERICA INC. ("OAI") ON OR ABOUT AUGUST 15, 2002 FOR EVALUATION FOLLOWING THE REPORTED PERFORATION. OAI'S DESIGNATED COMPLAINT HANDLING UNIT CONDUCTED A PRELIMINARY INVESTIGATION THAT CONSISTED PRIMARILY OF A VISUAL INSPECTION OF THE DEVICE AND TAKING SEVERAL MEASUREMENTS. THE INVESTIGATION INDICATED THAT THE INSERTION TUBE (THE PART OF THE ENDOSCOPE THAT IS INSERTED INTO THE PT) WAS SLIGHTLY STIFFER THAN EXPECTED FOR THIS MODEL (BUT NOT OUTSIDE OF THE OPERATIONAL RANGE). ADDITIONALLY, THE DEVICE IN QUESTION HAD NUMEROUS SIGNS OF PHYSICAL AND CHEMICAL DAMAGE, E.G., A BUCKLE AND DENT ON THE LIGHT GUIDE TUBE, WHICH IS NOT INSERTED INTO THE PT, AND A DISCOLORATION INSIDE THE SUCTION CHANNEL, WHICH IS ALSO NOT INSERTED INTO THE PT. OAI ASKED THE REPORTING FACILITY FOR PERMISSION TO RETURN THE DEVICE TO THE MANUFACTURING FACILITY, OPERATED BY OLYMPUS OPTICAL CO., LTD. ("OT"), BUT THAT PERMISSION WAS NOT GRANTED. IN LIEU OF RETURNING THE DEVICE, OAI SHARED PRELIMINARY INVESTIGATION RESULTS WITH OT. IN PARTICULAR, OAI ASKED IF THE SLIGHTLY STIFFER INSERTION TUBE COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. OT RESPONDED THAT THERE ARE MANY CONTRIBUTING FACTORS ASSOCIATED WITH COLON PERFORATIONS, INCLUDING BUT NOT LIMITED TO, FORCEFUL TIP INSERTION (REGARDLESS OF THE STIFFNESS OF THE INSERTION TUBE), ASSOCIATED WITH SPECIFIC CONDITIONS OF THE COLON, SUCH AS DIVERTICULAR ORIFICE, STRICTURE AND ACUTE BENDING, EXCESSIVE LOOPING OF THE INSERTION TUBE, CAUSED BY THE SHAPE OF THE COLON, OVER INFLATION BY THE ENDOSCOPIST, PHYSICIAN INEXPERIENCE, AND BIOPSY. GIVEN THESE FACTORS AND THE REPORTED CONDITION OF THE COLONOSCOPE WHEN IT WAS RETURNED TO OAI, OT HAS CONCLUDED THAT THERE IS NO REALTIONSHIP BETWEEN THE ENDOSCOPE AND THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SCOPE FDF OLYMPUS PCF-160AL *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R