BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 7817464 · Received August 27, 2018

    Report

    Report Number
    8010047-2018-01651
    Event Type
    Malfunction
    Date Received
    August 27, 2018
    Date of Event
    August 1, 2018
    Report Date
    October 23, 2018
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT CH-S400-XZ-EB, THERE WAS NO IRREGULARITY FOUND. THE SUBJECT CH-S400-XZ-EB WAS NOT RETURNED TO OMSC FOR EVALUATION, OMSC COULD NOT EVALUATE THE SUBJECT CH-S400-XZ-EB. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED, HOWEVER THERE IS POSSIBILITY OF THIS PHENOMENON IS ATTRIBUTED TO FAILURE OF THE CAMERA CABLE OF THE SUBJECT CH-S400-XZ-EB BY THE FOLLOWING. CAMERA CABLE OF THE SUBJECT CH-S400-XZ-EB WAS BROKEN. OXIDATION WAS OCCURRED AT THE CONNECTOR OF THE SUBJECT CH-S400-XZ-EB. THE CH-S400-XZ-EB INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT CH-S400-XZ-EB WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC). AS A RESULT OF INVESTIGATION, OMSC FOUND THE TRACE THAT THE CAMERA CABLE OF THE SUBJECT CH-S400-XZ-EB WAS PULLED STRONG. OMSC JUDGED THAT THE CAMERA CABLE OF THE SUBJECT CH-S400-XZ-EB WAS DISCONNECTED. OLYMPUS STATED THE APPROPRIATE HANDLING OF CH-S400-XZ-EB AND THE COUNTER MEASURES AGAINST ABNORMALITIES IN THE INSTRUCTION MANUAL OF CH-S400-XZ-EB AS THE FOLLOWING. DO NOT COIL THE CAMERA CABLE WITH A DIAMETER OF LESS THAN 20 CM. THE CAMERA CABLE MAY BE DAMAGED. BE CAREFUL NOT TO TWIST THE CAMERA CABLE WHEN IT IS COILED. THE CAMERA CABLE MAY BE DAMAGED. THE CABLE CAN BE COILED WITHOUT TWISTS BY PILING LOOPS THAT ARE MADE BY CROSSING THE CABLE IN FRONT AND BACK ALTERNATELY. NEVER EXCESSIVELY BEND, PULL, TWIST, COIL, SQUEEZE, OR CRUSH THE CAMERA CABLE, WHICH COULD DAMAGE THE CAMERA CABLE. NEVER EXCESSIVELY PULL THE CAMERA CABLE, BUT STRAIGHTEN IT GRADUALLY WHEN IT IS COILED. THE CAMERA CABLE COULD BE DAMAGED. DO NOT USE EXCESSIVE FORCE WHEN WIPING THE EXTERNAL SURFACES OF THE CAMERA CABLE. THE CAMERA CABLE COULD BE DAMAGED. NEVER ATTEMPT TO LIFT THE ENTIRE ASSEMBLY BY THE CAMERA CABLE WHILE THE CAMERA HEAD IS ATTACHED TO THE ENDOSCOPE. THE CAMERA CABLE COULD BE DAMAGED. NEVER USE A CLAMP OR FORCEPS TO ATTACH THE CAMERA CABLE TO ANOTHER OBJECT. THE CAMERA CABLE COULD BE DAMAGED. DO NOT PULL OUT THE VIDEO CONNECTOR BY PULLING THE CAMERA CABLE. EQUIPMENT DAMAGE MAY OCCUR. DO NOT ROTATE THE CAMERA HEAD TOO MANY TIMES IN THE SAME DIRECTION. THE CAMERA CABLE MAY BECOME TWISTED, CAUSING EQUIPMENT FAILURE. THEREFORE, OMSC CONCLUDED THAT THIS PHENOMENON IS ATTRIBUTED TO THE INAPPROPRIATE HANDLING BY THE USER. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT CH-S400-XZ-EB WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) YET. THE USER WILL NOT RETURN THE SUBJECT CH-S400-XZ-EB. THE CH-S400-XZ-EB INSTRUCTION MANUAL STATES THE CORRESPONDING METHOD WHEN THERE IS AN ABNORMALITY FOR THE DEVICE. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    DURING THE UNSPECIFIED PROCEDURE, THE IMAGE DISPLAYED ON THE UNSPECIFIED MONITOR WAS DISAPPEARED. THE USER REPLACED THE USED OTV-S400 WITH THE SIMILAR DEVICE AND COMPLETED THE PROCEDURE. (REFERENCE (B)(4))0 ACCORDING TO THE SUPPLEMENTAL INVESTIGATION, IT WAS FOUND THAT THIS PHENOMENON WAS NOT CAUSED BY OTV-S400, IT WAS CAUSED BY THE SUBJECT CH-S400-XZ-EB. THERE WERE NO REPORTS OF PATIENT INJURIES RELATED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661907 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1