BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 11548760 · Received March 23, 2021

    Report

    Report Number
    8010047-2021-04056
    Event Type
    Malfunction
    Date Received
    March 23, 2021
    Report Date
    April 22, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    UDI-DI
    04953170393204
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO OLYMPUS KOREA CO., LTD. (OKR) FOR EVALUATION. FROM THE DEVICE INSPECTION RESULT BY OKR, OMSC CONFIRMED THAT THE CAMERA CABLE WAS TWISTED AND THE CIRCUIT WAS SHORT-CIRCUITED, CAUSING NOISE IN THE ENDOSCOPIC IMAGE. THEREFORE, IT IS POSSIBLE THAT THE ENDOSCOPIC IMAGE WAS TEMPORARILY NOT DISPLAYED WHEN THE CIRCUIT WAS SHORT-CIRCUITED. IN ADDITION, THE CABLE UNIT MAY HAVE FAILED DUE TO UNEXPECTED STRESS CAUSED BY THE USER'S HANDLING. THE INSTRUCTION MANUAL PROVIDES PREVENTIVE MEASURES AGAINST THE REPORTED FAILURE MODE. DEVICE HISTORY RECORD (DHR) REVIEW INDICATES THAT THE PRODUCT WAS MANUFACTURED AND TESTED IN ACCORDANCE WITH ALL APPLICABLE PROCEDURES AND MET ALL FINAL PRODUCT RELEASE CRITERIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) BUT WAS RETURNED TO (B)(6) FOR EVALUATION. (B)(6) INSPECTED THE DEVICE AND CONFIRMED THE FOLLOWING; DURING THE INSPECTION OF THE DEVICE, THE ENDOSCOPIC IMAGE OF THE DEVICE WAS INTERMITTENTLY NOISY. THIS MAY HAVE BEEN CAUSED BY A MALFUNCTION IN THE OPEN CIRCUIT, SUCH AS A TWIST IN THE CAMERA CABLE. 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)(6) CO., LTD. (B)(6) AND FOUND THAT WHEN THE DEVICE CONNECTED TO THE VIDEO SYSTEM CENTER, AN ERROR OCCURRED AND THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. WHEN THE DEVICE WAS RECONNECTED, THE ENDOSCOPIC IMAGE WAS DISPLAYED PROPERLY. THE DEVICE WAS A DEMONSTRATION PRODUCT AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452193 HD 3CMOS AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD OWN OLYMPUS MEDICAL SYSTEMS CORP. CH-S200-XZ-EA 04953170393204

    Patients

    Seq Age Sex Outcome Treatment
    1