BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE

    MDR report key: 19219001 · Received May 1, 2024

    Report

    Report Number
    9610773-2024-30256
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 3, 2024
    Report Date
    June 21, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761075015
    PMA / PMN Number
    K190744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D9 - 4/5/2024, G4 - K190744, H4 - 6/21/2018. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND NO ADDITIONAL FINDINGS. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE FOLLOWING LED TO THE MALFUNCTION: THE VIDEO CABLE IS BROKEN AND THEREFORE THE IMAGE IS NOT DISPLAYED. A DEVICE HISTORY RECORD REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    MULTIPLE FOLLOW UPS WERE MADE TO GATHER ADDTIONAL INFORMATION REGARDING THE EVENT REPORTED , HOWEVER WERE UNSUCCESSFUL AS NO RESPONSE IS RECEIVED FROM THE CUSTOMER. THE EVALUATION OF THE EVENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO TELESCOPE IMAGE TURNED BLACK DURING SURGERY. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VIDEO TELESCOPE IMAGE TURNED BLACK DURING SURGERY. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072924 VIDEO TELESCOPE "ENDOEYE HD II", 5.4 MM, 30°, AUTOCLAVABLE LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET OLYMPUS WINTER & IBE GMBH WA50052A 04042761075015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown