BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLE

    MDR report key: 13057132 · Received December 21, 2021

    Report

    Report Number
    9610773-2021-00367
    Event Type
    Injury
    Date Received
    December 21, 2021
    Date of Event
    November 27, 2021
    Report Date
    February 21, 2022
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FGC
    UDI-DI
    04042761077545
    PMA / PMN Number
    K151191
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER HEALTH CARE PROFESSIONAL: PHARMACY TECHNICIAN. THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. THE DEFINITIVE CAUSE OF THE USER¿S EXPERIENCE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE UPDATED UPON COMPLETION OF THE INVESTIGATION OR UPON RECEIPT OF ADDITIONAL RELEVANT INFORMATION.

    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 CAUSE OF THE REPORTED ISSUES IS MOST LIKELY DUE TO INADEQUATE REPROCESSING AS WELL AS APPLICATION OF FORCE SUCH AS FALL OR IMPACT. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE USING AN OES ELITE AUTOCLAVABLE TELESCOPE, AFTER HALF AN HOUR OF USE, THE VIDEO SCREEN DARKENED NOTING INFILTRATED OPTICS. THIS REQUIRED THE PROCEDURE TO BE CONVERTED TO AN OPEN PROCEDURE. THE CUSTOMER CONFIRMED THE TELESCOPE HAD NOT BEEN DROPPED PRIOR TO THIS OCCURRENCE. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED, THE PATIENT'S CURRENT CONDITION IS REPORTED AS "VERY WELL. NO URINARY COMPLAINTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948912 TELESCOPE "OES ELITE", 4 MM, 30°, HD, AUTOCLAVABLE URETHROSCOPE FGC OLYMPUS WINTER & IBE GMBH WA2T430A 800805 04042761077545

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention