BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5FR GRASPER FORCEP

    MDR report key: 11466274 · Received March 11, 2021

    Report

    Report Number
    3003790304-2021-00045
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Report Date
    April 6, 2021
    Manufacturer
    LAKE REGION MEDICAL
    Product Code
    HIH
    PMA / PMN Number
    EXEMPT-HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS NO LOT/SERIAL NUMBER WAS PROVIDED. THE SUBJECT DEVICE HAS NOT BEEN MADE AVAILABLE TO OLYMPUS FOR EVALUATION. THE CUSTOMER WAS UNABLE TO PROVIDE DETAILS REGARDING DEVICE DISPOSITION. A DEFINITIVE ROOT CAUSE OF THE REPORTED PHENOMENON CANNOT BE DETERMINED AS THIS TIME. OLYMPUS WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS DEVICE.

    Description of Event or Problem · 0

    FURTHER COMMUNICATION WITH THE CUSTOMER CONVEYED THE FOLLOWING INFORMATION: THE PROBLEM WITH THE GYA-5 FORCEPS BROKEN TIPS WAS FIRST NOTICED DURING REPROCESSING. NO OTHER DEVICES WERE INVOLVED IN THE EVENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED AND WAS NOTED TO BE A MODEL DEVICE THAT IS NON SERVICEABLE. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED AT THIS TIME. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATIONS.

    Description of Event or Problem · 1

    TIPS WERE REPORTED TO BE BROKEN. NO FURTHER INFORMATION PROVIDED REGARDING THE EVENT. NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357114 5FR GRASPER FORCEP 5FR GRASPER FORCEP HIH LAKE REGION MEDICAL GYA-5 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1