BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5FR GRASPER FORCEP

    MDR report key: 10605892 · Received September 30, 2020

    Report

    Report Number
    3003790304-2020-00094
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 4, 2020
    Report Date
    January 14, 2021
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    HIH
    PMA / PMN Number
    EXEMPT-HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE TREND ANALYSIS AND INVESTIGATION CONCLUSION. PHYSICAL EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE CUSTOMER IS NOT RETURNING DEVICE AND NO PICTURES HAVE BEEN PROVIDED. A DHR REVIEW COULD NOT BE PERFORMED ON THIS DEVICE BECAUSE THE SERIAL NUMBER IS UNKNOWN. THE ROOT CAUSE OF THE REPORTED ISSUE WAS NOT IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. THE CAUSE OF THE ISSUE CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE USER WAS USING THE GRASPER GYA-5 AND THE PIECES FROM THE DEVICE JAW BROKE OFF AND FELL INTO THE PATIENT. ACCORDING TO THE REPORTER, THE FACILITY OR (OPERATING ROOM) TEAM REMOVED THE BROKEN PIECES FROM THE PATIENT. THE PATIENT UNDERWENT AN X-RAY TO FIND OUT IF EVERYTHING (ALL THE PIECES) THAT FELL WERE REMOVED. NO FURTHER DETAILS WERE PROVIDED REGARDING THE EVENT. NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070384 5FR GRASPER FORCEP 5FR GRASPER FORCEP HIH LAKE REGION MEDICAL GYA-5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1