BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO SYSTEM CENTER

    MDR report key: 12493260 · Received September 18, 2021

    Report

    Report Number
    8010047-2021-11945
    Event Type
    Malfunction
    Date Received
    September 18, 2021
    Report Date
    September 18, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K122831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED DUE TO THE FAILURE OF THE PRINTED-CIRCUIT BOARD AND THE VIDEO CONNECTION. IN ADDITION, (B)(4) FOUND THE SUBJECT DEVICE COULD NOT RECOGNIZE THE SURGICAL DEVICE DUE TO THE FAILURE OF THE VIDEO CONNECTOR SOCKET. OMSC REVIEWED THE DEVICE HISTORY RECORD (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BASED UPON THE INFORMATION FROM (B)(4), OMSC CONSIDERED THAT THE REPORTED PHENOMENA WERE ATTRIBUTED TO THE FOLLOWINGS. THE ERROR B30 WAS DISPLAYED DUE TO THE FAILURE OF THE PRINTED-CIRCUIT BOARD; IT MIGHT BE ATTRIBUTED TO THE COMMUNICATION FAILURE WITH THE ENDOSCOPE DUE TO THE ACCIDENTAL FAILURE OF THE COMPONENTS ON THE PRINTED-CIRCUIT BOARD WHICH RELATING THE COMMUNICATION WITH THE ENDOSCOPE. THE ERROR B30 WAS DISPLAYED DUE TO THE FAILURE OF THE VIDEO CONNECTION AND THE SUBJECT DEVICE COULD NOT RECOGNIZE THE SURGICAL DEVICE DUE TO THE VIDEO CONNECTOR SOCKET; IT MIGHT BE ATTRIBUTED TO THE COMMUNICATION FAILURE WITH THE ENDOSCOPE BY THE UNSTABLE CONTACT OF THE CONNECTOR DUE TO THE FAILURE OF THE VIDEO CONNECTOR SOCKET WHICH WAS CAUSED BY THE WEAR OF THE CONTACT AND/OR THE WEAR OF THE LOCKING FUNCTION BY REPEATEDLY LONG-TERM USE, OR EXCESSIVE FORCE BEING APPLIED TO THE VIDEO CONNECTOR BY THE USER BECAUSE OVER FIVE YEARS HAD PASSED FROM THE SUBJECT DEVICE HAD BEEN MANUFACTURED. OLYMPUS STATED THE APPROPRIATE HANDLING OF CV-170 AND THE COUNTER MEASURES AGAINST ABNORMALITIES IN THE INSTRUCTION MANUAL OF CV-170.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT BEFORE A GASTROSCOPY PROCEDURE, IT WAS FOUND THAT THE SCOPE COMMUNICATION ERROR B30 WAS DISPLAYED. THE USER CLEANED THE CONTACTS WITH AN UNSPECIFIED MULTIFUNCTION SPRAY. THEN THE CUSTOMER SUPPORT OF OLYMPUS (B)(4) ASKED THE USER TO CLEAN THE CONTACTS WITH ALCOHOL, HOWEVER THE ISSUE WAS NOT RESOLVED. THE DIFFERENT ENDOSCOPE WAS CONNECTED TO THE SUBJECT DEVICE, ALSO THE ISSUE WAS NOT RESOLVED. THE PATIENT WAS UNDER ANESTHESIA. THE INTENDED PROCEDURE WAS NOT COMPLETED AND THE PROCEDURE WAS POSTPONED. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390825 VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-170

    Patients

    Seq Age Sex Outcome Treatment
    1