BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCISSORS, 5 FR., SEMIFLEXIBLE

    MDR report key: 17769882 · Received September 18, 2023

    Report

    Report Number
    9610773-2023-02617
    Event Type
    Injury
    Date Received
    September 18, 2023
    Date of Event
    August 23, 2023
    Report Date
    January 16, 2024
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    NWW
    UDI-DI
    04042761006897
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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 REPORTED FAILURE (ONE BLADE OF THE SCISSORS WAS MISSING) WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 10 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE REPORTED ISSUE (BROKEN DISTAL END) WAS CAUSED BY WEAR AND TEAR OF THE DEVICE. THIS SUPPLEMENTAL REPORT INCLUDES AN UPDATE TO D9 AND H3 FROM THE INITIAL MEDWATCH. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, REPORTED THREE THE SCISSORS, 5 FR., SEMIFLEXIBLE DEMO SETS SENT INTO FORTH VALLEY FOR THE CONSULTANT TO TEST THE SHEATH AND INSTRUMENTS. THE SECOND SET, SCISSORS WERE MISSING A BLADE, SO NOT USEABLE AND NO BUNGS ON THE SET. IT WAS FURTHER NOTED, THIS EVENT OCCURRED DURING PREPARATION FOR USE, THE KIT WAS OPENED AS PATIENT CAME IN ANESTHETIZED AND THE HYSTEROSCOPE BIOPSY PROCEDURE WAS DELAYED BY 30 MINUTES. THEY USED THE BIOPSY GRASPERS, WHICH TOOK A SUBSTANTIAL AMOUNT OF TIME. THE TIME DELAY LED TO THE LAST PATIENT BEING CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS (B)(6) TO CAPTURE THE MULTIPLE INSTANCES WHERE PATIENT PROCEDURES WERE DELAYED. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6) FOR THE SECOND TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1903334 SCISSORS, 5 FR., SEMIFLEXIBLE HYSTEROSCOPE ACCESSORIES NWW OLYMPUS WINTER & IBE GMBH A4826 13XW 04042761006897

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other