BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE LIGATING DEVICE

    MDR report key: 7406666 · Received April 9, 2018

    Report

    Report Number
    2951238-2018-00234
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Report Date
    March 8, 2019
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FHN
    PMA / PMN Number
    PK984255
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO MAKE A CORRECTION ON THE PROCODE FROM FDT TO FHN.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME. LIMITED INFORMATION WAS PROVIDED BY THE USER FACILITY REGARDING THE PATIENT, PROCEDURE AND THE DEVICE AS MULTIPLE ATTEMPTS WERE MADE TO GATHER MORE DETAILED INFORMATION REGARDING THE REPORTED INCIDENT; HOWEVER NO ADDITIONAL INFORMATION WAS OBTAINED. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR IF THE DEVICE IS RETURNED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DEVICE BROKE INSIDE THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249586 SINGLE USE LIGATING DEVICE SINGLE USE LIGATING DEVICE FHN OLYMPUS MEDICAL SYSTEMS CORP. HX-400U-30 77B

    Patients

    Seq Age Sex Outcome Treatment
    1