BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 11537153 · Received March 22, 2021

    Report

    Report Number
    8010047-2021-04001
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    February 24, 2021
    Report Date
    April 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. DEVICE INSPECTION BY OLYMPUS SINGAPORE PTE. LTD. CONFIRMED FOLLOWINGS; THE CCD UNIT WAS OUT OF ORDER. DUE TO THIS FAILURE, THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THE COUPLER UNIT WAS CORRODED. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE DEVICE WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. BASED ON THE COUPLER CORROSION, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) ASSUMED THAT THE REPORTED EVENT WAS CAUSED BY FOLLOWING FLOW; MOISTURE ENTERED THE INSIDE OF THE CAMERA HEAD BY THE WRONG REPROCESSING METHOD. MOISTURE BROKE THE ELECTRONIC CIRCUITS INSIDE THE DEVICE. A BROKEN ELECTRONIC CIRCUIT CAUSED POOR COMMUNICATION WITH THE VIDEO PROCESSOR. DUE TO POOR COMMUNICATION, THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    OLYMPUS INSPECTED THE DEVICE AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) AND FOUND FOLLOWINGS; THE REPORTED EVENT WAS REPRODUCED. THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THE DEVICE FAILED WITH THE INSPECTION ITEMS "CHECKING SIGNALS", "CHECKING ENDOSCOPIC IMAGE ON THE MONITOR", "CHECKING IMAGE QUALITY" AND "CHECKING OPERABILITY". THE EXACT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN IDENTIFIED BY LEGAL MANUFACTURER OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THIS DEVICE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE ENDOSCOPIC IMAGE BLACKED OUT DURING A PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434570 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-10E

    Patients

    Seq Age Sex Outcome Treatment
    1