BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE

    MDR report key: 19383770 · Received May 23, 2024

    Report

    Report Number
    9610773-2024-01297
    Event Type
    Injury
    Date Received
    May 23, 2024
    Report Date
    October 1, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNS
    UDI-DI
    04042761066242
    PMA / PMN Number
    K030194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT HAS BEEN SUBMITTED BY THE IMPORTER UNDER THIS MDR REPORT NUMBER 2429304-2024-0000272.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION AND THE INFORMATION RECEIVED, THE ROOT CAUSE OF THE SUGGESTED EVENT COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THEY HEARD A RUMOR THERE WAS A PERFORATION WHILE USING THE SUBJECT DEVICE DURING A GYNECOLOGY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2401 WORKING ELEMENT, PASSIVE, FOR RESECTION IN SALINE RIGID ENDOSCOPE WORKING GUIDE KNS OLYMPUS WINTER & IBE GMBH WA22367A 04042761066242

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other (B)(6) OUTER SHEATH, 8.5 MM/26 FR., 2 STOPCOCKS| (B)(6) VIDEO ADAPTER "AR-T12EA", EYEPIECE CUP