BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING SET, IRRIGATION, FC

    MDR report key: 17210129 · Received June 27, 2023

    Report

    Report Number
    9610617-2023-00820
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    September 22, 2020
    Report Date
    June 19, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    HIF
    PMA / PMN Number
    K936231
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 20-0074 CORRECTIVE ACTION 6. THE USER USED THE WRONG TUBING SET FOR THE PLANNED HYSTEROSCOPIC PROCEDURE. THE USER USED 031524-01 TUBING SET, IRRIGATION, FC; LOT 200414. THIS TUBING SET IN COMBINATION WITH THE ROLLER PUMP (ENDOMAT HAMOU) IS NOT INDICATED FOR HYSTEROSCOPIC PROCEDURES. THE FIELD OF APPLICATION IS AUTOMATICALLY SELECTED WHEN THE CORRECT TUBING CARTRIDGE FOR THE RESPECTIVE FIELD OF APPLICATION IS INSERTED. THE DEVICE DETERMINES THE INTENDED FIELD OF APPLICATION FROM THE DIFFERENT "ENCODINGS" OF THE TUBING CARTRIDGE AND THEN AUTOMATICALLY SELECTS THE APPROPRIATE OPERATING PARAMETERS. THE SELECTED INDICATION IS VISIBLE ON THE SCREEN OF THE DEVICE. THE LABEL OF THE TUBING SET CONTAINS THE FIELD OF APPLICATIONS. THE RELATED IFU CONTAINS A WARNING TO MAKE SURE TO USE CARTRIDGES ONLY FOR APPLICATIONS SPECIFIED ON THEIR PACKAGING. THE ROOT CAUSE IS DEEMED AS USE ERROR AND NOT RELATED TO A DEVICE FAILURE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS EVENT WITH A TUBING SET, IRRIGATION, FC. ACCORDING TO THE INFORMATION RECEIVED A HYSTEROSCOPY WAS PERFORMED IN WHICH THE HAMOU ENDOMAT SCB (ROLLER PUMP) WAS ALLEGEDLY EQUIPPED WITH THE WRONG CASSETTE TUBING SET. THEREFORE, THE DEVICE RAN WITH THE PRESSURE AND FLOW PARAMETERS OF THE LAPAROSCOPY PROGRAM. AS A RESULT, THE PATIENT EXPERIENCED A SEVERE TUR SYNDROME. THE PATIENT WAS SUBSEQUENTLY IN INTENSIVE CARE FOR A LONGER PERIOD OF TIME, BUT SURVIVED THE INCIDENT. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929794 TUBING SET, IRRIGATION, FC TUBING SET, IRRIGATION, FC HIF KARL STORZ SE & CO. KG 031524-01 200414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| L| O| R 26331120-1 HAMOU ENDOMAT SCB, SN: (B)(6)