BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET, IRRIGATION, FC

    MDR report key: 20774154 · Received November 25, 2024

    Report

    Report Number
    9610617-2024-00471
    Event Type
    Malfunction
    Date Received
    November 25, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 13, 2024
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    OCX
    PMA / PMN Number
    K180735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: ARTICLE: 031524-10. LEAK OF THE PRESSURE DOME SUBASSEMBLY. ONE OF THE PRESSURE TRANSMITTING MEMBRANES HAS BEEN FOUND OUT OF SPECIFICATION. WHICH RESULTED IN NOT CREATING ENOUGH SEALING PRESSURE FOR HIGH PRESSURE TO SEAL THE PRESSURE DOME SUFFICIENT IF HIGH PRESSURES ARE APPLIED. WORN OUT INJECTION MOULDING TOOL FOR THE SILICONE MEMBRANES. THE INJECTION MOULDING TOOL FOR THE MEMBRANE GOT REPAIRED AND NEW QUALIFIED. THE RISK IS COVERED IN THE RELATED RISK FILE (SAP-ID: (B)(4)), VERSION: BB, RISK-ID: 5.5.02). THE OCCURRENCE LEVEL WAS RATED WITH 1 (LESS THAN (B)(4).) ACCORDING TO THE TREND ANALYSIS, NO FURTHER INCIDENT WAS FOUND. IN CONCLUSION, THE CALCULATED COMPLAINT RATE IS (B)(4) AND THEREFORE LOWER THAN THE EXPECTED COMPLAINT RATE. THE REVIEW OF THE RISK ASSESSMENT REVEALED THAT THE OVERALL OCCURRENCE LEVEL IS WITHIN THE ANTICIPATED OCCURRENCE AND STILL ADEQUATE. FURTHERMORE, IFU 97000138 V2.5, 03/2023 REQUIRES THE SYSTEM TO BE TESTED UNDER POINT 10. OPERATION ON PAGE 5. BASED ON THE INVESTIGATION RESULTS, THE REPORTING DECISION WAS ADJUSTED ACCORDINGLY. NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED. NO SIMILAR LISTED EVENT(S) THAT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. THE CASE IS DEEMED NOT REPORTABLE. ARTICLE: UP210. PRODUCT NOT RECEIVED FOR INVESTIGATION AND FURTHERMORE NOT CAUSAL. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE SURGERY, THE TUBING PRODUCT SHOWED LEAKAGE. NO HARM TO PATIENT, USER OR THIRD PARTIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068900 TUBING SET, IRRIGATION, FC TUBING SET OCX KARL STORZ SE & CO. KG 031524-10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown