BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIVE S 3.5X65, STERILE, FOR SINGLE USE,

    MDR report key: 19697788 · Received July 8, 2024

    Report

    Report Number
    9610617-2024-00199
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 10, 2024
    Report Date
    October 30, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    CAL
    UDI-DI
    04048551422519
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER INVESTIGATION BY THE MANUFACTURING SITE: AS NO PRODUCT HAS BEEN RETURNED A FINAL DETERMINATION OF THE ROOT CAUSE IS NOT POSSIBLE. IN SIMILAR CASES WITH THE SAME PRODUCT, EXCESSIVE FORCE DURING APPLICATION LEAD TO DAMAGES AT THE ENDOSCOPE. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS USED AND CONTAMINATED, AND THUS WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING DOUBLE-LUMEN PLACEMENT PROCEDURE ON (B)(6) 2024, THE DISTAL TIP OF THE SCOPE BROKE. NO PATIENT INJURY WAS REPORTED, AND THEY WERE ABLE TO COMPLETE THE PROCEDURE USING A BACK-UP STETHOSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1391617 FIVE S 3.5X65, STERILE, FOR SINGLE USE, FIVE S 3.5X65, STERILE, FOR SINGLE USE, CAL KARL STORZ SE & CO. KG 091361-06 500099740 04048551422519

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown