BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEOSCOPE CABLE 150

    MDR report key: 11168552 · Received January 14, 2021

    Report

    Report Number
    8010047-2021-01349
    Event Type
    Malfunction
    Date Received
    January 14, 2021
    Date of Event
    September 8, 2020
    Report Date
    October 12, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDF
    UDI-DI
    04953170228759
    PMA / PMN Number
    K051645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION AND TO CORRECT INFORMATION PROVIDED ON THE INITIAL REPORT. BASED ON THE RESULTS OF THE INVESTIGATION, SINCE THE DEVICE WAS MANUFACTURED OVER EIGHT YEARS AGO, THE CABLE UNIT AND THE PRINTED CIRCUIT BOARD WERE LIKELY WORN DUE TO REPEATED USE FOR A LONG PERIOD, CAUSING THE IMAGE TRANSMISSION AND COMMUNICATION BETWEEN THE SCOPE AND THE VIDEO PROCESSOR TO BECOME DISTURBED, RESULTING IN THE IMAGE LOSS AND E315 ERROR (NON-OBJECT SCOPE CONNECTION ERROR).

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED. CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 08-SEP-2020. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), THEREFORE OMSC CANNOT INVESTIGATE THE DEVICE. DEVICE HISTORY RECORD REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. THE DEVICE WAS MANUFACTURED ABOUT EIGHT YEARS AGO. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS POSSIBILITY THAT THIS PHENOMENON IS ATTRIBUTED TO THE DEFECT OF THE CABLE UNIT AND CIRCUIT BOARD DUE TO LONG-TERM USE. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE ENDOSCOPIC IMAGE DID NOT APPEAR DURING PREPARATION FOR USE. OLYMPUS ENGINEER VISITED THE USER FACILITY AND FOUND THAT THERE WAS A PROBLEM WITH MAJ-1558. THEN, OLYMPUS INSPECTED THE MAJ-1558 AT THE SERVICE DEPARTMENT OF OLYMPUS MEDICAL SYSTEMS INDIA PRIVATE LIMITED AND FOUND THAT NO ENDOSCOPIC IMAGE WAS DISPLAYED AND THE ERROR 315 OCCURRED. REPORTEDLY, CABLE UNIT AND CIRCUIT BOARD WERE DEFECTIVE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66379 VIDEOSCOPE CABLE 150 VIDEOSCOPE CABLE FDF OLYMPUS MEDICAL SYSTEMS CORP. MAJ-1558 04953170228759

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown