BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELESCOPE, 10 MM, 0°, QUICK LOCK, AUTOCLAVABLE

    MDR report key: 18040016 · Received October 31, 2023

    Report

    Report Number
    9610773-2023-03119
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 4, 2023
    Report Date
    August 12, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    HET
    UDI-DI
    04042761001557
    PMA / PMN Number
    K923982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G4:K923982/ K912362. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS REPAIR CENTER FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE EVALUATION FOUND THAT THE LIGHT GUIDE (LG) POST WAS BROKEN OFF. IT WAS ALSO FOUND THAT THERE WERE MINOR DENTS ON THE OUTER TUBE, DISTAL FIBER BREAKAGE AND DEBRIS IN OPTICAL SYSTEM. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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 23 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE CUSTOMER'S REPORTABLE MALFUNCTION WAS CONFIRMED. A DEFINITIVE ROOT CAUSE WAS NOT IDENTIFIED, HOWEVER BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE MALFUNCTION WOULD LIKELY BE DUE TO EXCESSIVE USE AND, DUE TO THE AGE OF THE DEVICE, WEAR AND TEAR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE TELESCOPE, 10 MM, 0°, QUICK LOCK, AUTOCLAVABLE HAD A BROKEN LIGHT POST. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128533 TELESCOPE, 10 MM, 0°, QUICK LOCK, AUTOCLAVABLE LAPAROSCOPE HET OLYMPUS WINTER & IBE GMBH A5294A 108309 04042761001557

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown