BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K AUTOCLAVABLE CAMERA HEAD

    MDR report key: 12465580 · Received September 13, 2021

    Report

    Report Number
    8010047-2021-11657
    Event Type
    Malfunction
    Date Received
    September 13, 2021
    Report Date
    November 4, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170375552
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE VIDEO COMMUNICATION COULD NOT BE TRANSMITTED TO THE PROCESSOR, LEADING TO NO IMAGE AND COMMUNICATION ERRORS DUE TO THE DEFECTIVE CABLE, LIKELY CAUSED BY USER OPERATION. THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "·DO NOT COIL THE CAMERA CABLE WITH A DIAMETER OF LESS THAN 20 CM. THE CAMERA CABLE MAY BE DAMAGED. ·NEVER EXCESSIVELY PULL THE CAMERA CABLE, BUT STRAIGHTEN IT GRADUALLY WHEN IT IS COILED. THE CAMERA CABLE COULD BE DAMAGED. ·NEVER EXCESSIVELY BEND, PULL, TWIST, COIL, SQUEEZE, OR CRUSH THE CAMERA CABLE. 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." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE CUSTOMER¿S COMPLAINT OF AN ¿ E222/224¿ ERROR COULD NOT BE DUPLICATED. HOWEVER, THERE WAS NO IMAGE DISPLAYED DUE TO A FAULTY CABLE UNIT. IN ADDITION, THE REAR LABEL WAS NOTED TO BE FADING. THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING PREPARATION FOR USE, AN ¿E222/224 SCOPE COMMUNICATION¿ ERROR WAS OBSERVED AND NO IMAGE WAS DISPLAYED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363203 4K AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EA 04953170375552

    Patients

    Seq Age Sex Outcome Treatment
    1