BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA LLL COLONOVIDEOSCOPE

    MDR report key: 11033963 · Received December 18, 2020

    Report

    Report Number
    8010047-2020-10631
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    November 23, 2020
    Report Date
    January 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170305191
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO REPORT THE WITHDRAWAL OF MFR REPORT #8010047-2020-10631 AND CORRECT THE INITIAL REPORT. OLYMPUS RE-EVALUATED THE EVENT AND CONFIRMED THAT THE MALFUNCTION REPORTED IN THE INITIAL REPORT DID NOT OCCUR. THE ACTUAL PROBLEM WAS BROKEN ANGLE WIRE WHICH WAS NOT A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO THE SERVICE DEPARTMENT OF (B)(4) (OAZ) FOR EVALUATION. IN THE EVALUATION OF OAZ THE FOLLOWING WAS CONFIRMED; BENDING ANGLE DID NOT MEET SPECIFICATION. BENDING RETURN ANGLE WAS NOT WITHIN SPECIFICATION. THE ANGULATION CONTROL KNOB COULDN'T LOCK PROPERLY AND THE ANGULATION COULDN'T BE LOCKED. BENDING TUBE WAS HEAVY WHEN ANGLED THE BENDING SECTION. RIGHT/LEFT ANGULATION CONTROL KNOB WAS DAMAGED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) (OAZ) AND FOUND THAT THE UPWARD ANGLE WIRE WAS CUT AND THE ANGLE WIRE BECAME UNABLE TO MOVE AND THE BENDING SECTION KEPT ANGULATED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1499754 EVIS EXERA LLL COLONOVIDEOSCOPE COLONOVIDEOSCOPE FDF OLYMPUS MEDICAL SYSTEMS CORP. PCF-H190L 04953170305191

    Patients

    Seq Age Sex Outcome Treatment
    1