BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT TRAUMA LAPAROSCOPIC CHOLECYSTECTOMY

    MDR report key: 22423659 · Received July 7, 2025

    Report

    Report Number
    3002669946-2025-00001
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 15, 2025
    Manufacturer
    OWENS & MINOR DISTRIBUTION INC. OM45
    Product Code
    LRO
    PMA / PMN Number
    K954726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OWENS & MINOR DISTRIBUTION, INC. IS THE MANUFACTURER OF THE SURGI TRACK CONVENIENCE KIT CONTAINING THE DISPOSABLE SUCTION/IRRIGATOR WITH DISPOSABLE TIP WHICH WAS THE SOURCE OF THE COMPLAINT ISSUE. THE COMPLAINT COMPONENT (B)(4) WAS MANUFACTURED BY STRYKER CORPORATION (FDA REGISTRATION 1811755). THE SUPPLIER WAS NOTIFIED OF THIS INCIDENT ON JUNE 26, 2025. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RETURNED FOR EVALUATION, THE MANUFACTURER OF COMPLAINT DEVICE WAS PROVIDED CUSTOMER INFORMATION TO OBTAIN SAMPLE. OWENS AND MINOR IS THE MANUFACTURER OF THE SURGITRACK CONVENIENCE KIT CONTAINING THE COMPLAINT COMPONENT. THE COMPONENT IS PACKAGED WITH OTHER COMPONENTS TO COMPLETE SURGICAL PROCEDURE. THE COMPONENT IS NOT ALTERED OR FURTHER PROCESSED IN ANY WAY THAT COULD CONTRIBUTE TO THE MALFUNCTION REPORTED. THE COMPLAINT COMPONENT 250-070-520, LOT NUMBER 25105FG2, WAS MANUFACTURED BY STRYKER CORPORATION (FDA REGISTRATION 1811755). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS SENT TO STRYKER ON JUNE 26, 2025. THERE WERE 3 ATTEMPTS MADE REQUESTING THE COMPONENT MANUFACTURER COMPLETE THE SCAR ON JUNE 26, 2025, JULY 21, 2025 AND JULY 23, 2025. STRYKER DID NOT PROVIDE A COMPLETED SCAR RESPONSE; HOWEVER, THEY DID PROVIDE A RECALL NOTIFICATION FOR THE COMPLAINT COMPONENT. THE LOT NUMBERS LISTED IN THE RECALL NOTICE DO NOT INCLUDE THE SPECIFIC COMPLAINT LOT INVOLVED IN THIS CASE. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE CLINICIAN REPORTED THE SUCTION IRRIGATOR STARTED CREATING SMOKE DURING USE. THERE WAS NO INJURY TO THE PATIENT OR MEDICAL TREATMENT REQUIRED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141896 KIT TRAUMA LAPAROSCOPIC CHOLECYSTECTOMY SURGI TRACK KIT LRO OWENS & MINOR DISTRIBUTION INC. OM45 450045EB4F82 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown