BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBING SET, IRRIGATION, PC

    MDR report key: 17210123 · Received June 27, 2023

    Report

    Report Number
    9610617-2023-00907
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    July 7, 2020
    Report Date
    June 21, 2023
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OCX
    PMA / PMN Number
    K990910
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. WRTONG CODING PART HAS BEEN ASSEMBLED. WRONG KIT IN PACKAGING (LAPARASCOPIC INSTEAD OF HYSTEROSCOPIC). MANUFACTURING ERROR. 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, PC. ACCORDING TO THE INFORMATION THE CUSTOMER HAS RECEIVED A TUBE SET ENDOMAT FOR HYSTEROSCOPY, ITEM NUMBER MT031523-01. THE PRODUCT HAS THE LOT NO. 191008. THE INCIDENT IS DESCRIBED AS FOLLOWS: "LAPAROSCOPY" APPEARED ON THE DISPLAY INSTEAD OF "HYSTEROSCOPY". THE OUTER PACKAGING IS LABELED "GYN HYS", AND THERE IS APPARENTLY A TUBE SET FOR LAPAROSCOPY IN THE PACKAGING. A PROLONGED SURGERY WAS REPORTED. INFORMATION ABOUT PATIENTS HEALTH WAS NOT PROVIDED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221493 TUBING SET, IRRIGATION, PC TUBING SET, IRRIGATION, PC OCX KARL STORZ SE & CO. KG 031523-10 191008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other