BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLIMLINE OPERATIVE HYSTEROSCOPE INNER SHEATH/BRIDGE

    MDR report key: 11303794 · Received February 9, 2021

    Report

    Report Number
    1519132-2021-00004
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 6, 2021
    Report Date
    March 1, 2021
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    FAS
    UDI-DI
    00821925001787
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE THE EVENT DATE AND ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION. BASED ON THE LEGAL MANUFACTURER¿S INVESTIGATION, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THERE WERE NO PROBLEMS FOUND DURING THE MANUFACTURING OF THE DEVICE THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION FOUND THAT THE SHEATH OUTER TUBE WAS OBSERVED TO BE DENTED AND DAMAGED TIP WITH SHARP EDGES WERE NOTED. THE REPORTED ISSUE WAS CONFIRMED. THE PHYSICAL DAMAGE TO THE DEVICE CAN BE ATTRIBUTED TO USER MISHANDLING. PER THE (INSTRUCTION FOR USE), THE IFU FOR GY275L-SERIES (99-1044 _EJ) PROVIDES WARNINGS AND CAUTIONS TO ALERT THAT THE DEVICE MAY BE DAMAGED BY IMPROPER HANDLING. IT STATES "STUDY THIS MANUAL AND OTHER LABELING THOROUGHLY FOR SAFE HANDLING AND STORAGE. MISUSE OF INSTRUMENTS CAN CAUSE INJURY TO THE PATIENT AND COULD HAVE AN ADVERSE EFFECT ON THE PROCEDURE BEING PERFORMED. DO NOT DROP INSTRUMENTS OR ALLOW THEM TO BE STRUCK BY OTHER OBJECTS.

    Description of Event or Problem · 0

    DURING REPROCESSING, IT WAS REPORTED THAT THE TIP WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT ON THIS EVENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201100 SLIMLINE OPERATIVE HYSTEROSCOPE INNER SHEATH/BRIDGE SLIMLINE OPERATIVE HYSTEROSCOPE INNER SHEATH/BRIDGE FAS GYRUS ACMI, INC GY275L-B RXJS 00821925001787

    Patients

    Seq Age Sex Outcome Treatment
    1