BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 6479629 · Received April 11, 2017

    Report

    Report Number
    8010047-2017-00417
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    October 6, 2016
    Report Date
    March 7, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    PK061313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS SUBMITTING TO CORRECT "DEVICE PRODUCT CODE".

    Additional Manufacturer Narrative · 1

    OMSC INVESTIGATED THE SUBJECT DEVICE AND CONFIRMED THE FOLLOWING. HORIZONTAL LINE NOISE OCCURRED IN THE ENDOSCOPIC IMAGE. THIS NOISE OCCURRED DURING THE ELECTRONIC SHUTTER WAS ENABLED. THIS NOISE DID NOT OCCUR DURING THE ELECTRONIC SHUTTER WAS DISABLED. BASED ON THE INVESTIGATION RESULT, OMSC SURMISED THAT THIS PHENOMENON WAS CAUSED BY THE FOLLOWING MECHANISM. REGARDING THE VIDEO SIGNAL SENT TO THE CCD UNIT OF THE SUBJECT DEVICE, THE DISTURBANCE OCCURRED DURING THE ELECTRONIC SHUTTER WAS ENABLED DUE TO THE INFLUENCE OF ANY CHARACTERISTIC VARIATION OF THE DEVICE CONTROLLING THE ELECTRONIC SHUTTER ON THE CIRCUIT BOARD OF THE SUBJECT DEVICE. THE NOISE OCCURRED BY THIS DISTURBANCE OF THE VIDEO SIGNAL. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC TRIED TO REPRODUCE THE PHENOMENON USING THE SUBJECT DEVICE. THE ENDOSCOPIC IMAGE WAS DISPLAYED WITHOUT ANY ABNORMALITY, AND OMSC COULD NOT REPRODUCE THE PHENOMENON. OMSC WILL CONTINUE THE EVALUATION ABOUT THIS ISSUE. THE OTV-S7PROH-HD-10E INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THE FOLLOWING ON JANUARY 27TH 2017. DURING THE LAPAROSCOPY, THE USER FACILITY CONNECTED THE SUBJECT DEVICE TO A VIDEO PROCESSOR. AT THAT TIME, NOISE OCCURRED IN THE ENDOSCOPIC IMAGE. AS A RESULT OF ADDITIONAL SURVEY TO THE USER FACILITY, OLYMPUS WAS INFORMED THE FOLLOWING ON MARCH 15TH 2017. THE USER FACILITY REPLACED THE SUBJECT DEVICE WITH A SPARE DEVICE, AND COMPLETED THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT¿S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265042 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-10E

    Patients

    Seq Age Sex Outcome Treatment
    1