BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KT CHOLECYSTECTOMY LAPAROSCOPIC

    MDR report key: 22438044 · Received July 8, 2025

    Report

    Report Number
    3002669946-2025-00002
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    June 23, 2025
    Report Date
    August 15, 2025
    Manufacturer
    OWENS & MINOR DISTRIBUTION INC. OM45
    Product Code
    LRO
    UDI-DI
    10885632387661
    PMA / PMN Number
    K954726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT MADE AVAILABLE FOR EVALUATION. OWENS AND MINOR IS A REPACKAGER/RELABELLER WHO PLACES MEDICAL DEVICES INTO A FINAL MEDICAL CONVENIENCE KIT. THE COMPLAINT DEVICE IS NOT ALTERED OR FURTHER PROCESSED; THEREFORE, THE ROOT CAUSE IS ESTABLISHED BY THE COMPONENT MANUFACTURER FOR THIS INCIDENT. THE COMPLAINT COMPONENT (B)(6), LOT NUMBER 24347FG2, WAS MANUFACTURED BY STRYKER CORPORATION (FDA REGISTRATION 1811755). A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS INITIATED ON (B)(6) 2025. THERE WERE 3 ATTEMPTS MADE REQUESTING THE SUPPLIER COMPLETE THE SCAR ON (B)(6) 2025. STRYKER DID NOT PROVIDE A SCAR RESPONSE; HOWEVER, THEY DID PROVIDE A RECALL NOTIFICATION WHICH CONTAINED THE COMPLAINT COMPONENT AND LOT. THE RECALL NOTICE WAS DATED (B)(6) 2025 WHICH WAS THE SAME DATE AS THE ALERT DATE FOR THIS COMPLAINT. THE CUSTOMER LIKELY WAS NOT AWARE OF THE RECALL ON THE DATE OF THIS INCIDENT. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). OWENS AND MINOR HAS RECEIVED NO OTHER RELATED COMPLAINTS FOR THIS ISSUE FOR THIS KIT OR COMPLAINT DEVICE. 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

    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 250070520 WAS MANUFACTURED BY STRYKER CORPORATION (FDA REGISTRATION 1811755). THE SUPPLIER WAS NOTIFIED OF THIS INCIDENT ON (B)(6) 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.

    Description of Event or Problem · 0

    THE CLINICIAN REPORTED THEY PERFORMED A LAPAROSCOPIC CHOLECYSTECTOMY ON A PATIENT. THE CASE GOT COMPLICATED WHEN THE PATIENT WAS BLEEDING AND THE SUCTION IRRIGATOR DEVICE DID NOT FUNCTION (SUCTION) PROPERLY. THE STAFF GOT ANOTHER SUCTION IRRIGATOR DEVICE FROM THEIR OMNICELL AND THE REPLACEMENT DEVICE HAD THE SAME PROBLEM. THE SITUATION DELAYED PATIENT PROCEDURE WHILE TRYING TO LOCATE REPLACEMENT SUCTION DEVICE. ADDITIONAL INCIDENT DETAILS HAVE BEEN REQUESTED (B)(6) 2025) BUT NO FURTHER INFORMATION HAS BEEN RECEIVED TO-DATE FROM THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399619 KT CHOLECYSTECTOMY LAPAROSCOPIC GENERAL SURGERY KIT LRO OWENS & MINOR DISTRIBUTION INC. OM45 450045A70943 WO-029401-11 10885632387661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other