BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE

    MDR report key: 16499262 · Received March 7, 2023

    Report

    Report Number
    9610773-2023-00678
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 6, 2023
    Report Date
    May 10, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761074964
    PMA / PMN Number
    K111788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S COMPLAINT OF POOR IMAGE WAS CONFIRMED. THE IMAGE HAD VERTICAL STRIPES DUE TO A DEFECTIVE CABLE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE REPORTABLE EVENT, A PURPLE IMAGE, COULD NOT BE REPRODUCED. ALTHOUGH, THE IMAGE HAD VERTICAL STRIPES THERE WAS NO PURPLE DISCOLORATION. IN ADDITION, THE FOLLOWING NON-REPORTABLE MALFUNCTIONS WERE FOUND DURING THE DEVICE EVALUATION: DEFECTIVE CABLE UNIT, AND HEAVY DENTS ON THE OUTER TUBE. AS A RESULT OF THE DENTS ON THE OUTER TUBE, THE CHARGE COUPLED DEVICE (CCD) COULD NOT BE REMOVED AND NEEDED TO BE REPLACED AS WELL. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND REPAIR. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, THE ROOT CAUSE OF THE REPORTED DEFECT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY. IN GENERAL, THE CUSTOMER IS REQUIRED TO INSPECT THE DEVICE FOR DEFECTS, CHECK THE FUNCTION OF ALL DEVICES AND HAVE ALTERNATE EQUIPMENT PRIOR TO USE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE. ADDITIONAL PMA/510(K): K190744.

    Description of Event or Problem · 0

    IT WAS REPORTED TO OLYMPUS THAT A VIDEO TELESCOPE WAS RETURNED FOR REPAIR DUE TO POOR IMAGE. DURING THE INITIAL INSPECTION, THE IMAGE WAS PURPLE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60835 VIDEO TELESCOPE "ENDOEYE HD II", 10 MM, 0°, AUTOCLAVABLE LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH WA50040A 04042761074964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown