BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 19534163 · Received June 13, 2024

    Report

    Report Number
    0001056128-2024-00066
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 14, 2024
    Report Date
    June 13, 2024
    Manufacturer
    STRYKER-ENDOSCOPY LAKELAND 5300
    Product Code
    NLM
    UDI-DI
    00885825014438
    PMA / PMN Number
    K201511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION AS THE DEVICE IS HELD AT THE FACILITY FOR INTERNAL INVESTIGATION. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, INSPECTION WAS UNABLE TO BE PERFORMED. ADDITIONALLY, AS THE COMPLAINT DEVICE WAS NOT RETURNED, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. THE DEVICE WAS UNLIKELY TO HAVE BEEN RELEASED FROM STRYKER WITH THE REPORTED FAILURE MODE BASED ON OUR INVESTIGATION. THEREFORE, THE REPORTED EVENT COULD BE ATTRIBUTED TO: ACTIVATED ELECTROCAUTERY INSTRUMENT MELTS PART OF DEVICE. EXCESSIVE FORCE APPLIED. CONTACT WITH HARD OBJECT OR OTHER IMPROPER HANDLING. INSUFFICIENT STRUCTURAL INTEGRITY. SHIPPING/HANDLING DAMAGE OR EXTREME CONDITIONS. THE INSTRUCTIONS FOR USE (IFU) STATE: INSPECT THE INSTRUMENT AND PACKAGE BEFORE OPENING. THE CONTENTS OF THE PACKAGE ARE STERILE IF THE PACKAGING HAS NOT BEEN COMPROMISED. IF THE PACKAGE IS DAMAGED OR IF IT WAS OPENED AND THE INSTRUMENT WAS NOT USED, RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS FOR RESTERILIZATION BY ETHYLENE OXIDE (ETO) GAS. INSPECT THE INSTRUMENTS FOR ANY DAMAGE. DO NOT USE THE INSTRUMENT IF ANY DAMAGE IS NOTED. RETURN THE INSTRUMENT AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS IF IT IS NOT IN ACCEPTABLE CONDITION FOR SURGERY. THE REPORTED EVENT WILL CONTINUE TO BE MONITORED THROUGH POST-MARKET SURVEILLANCE. SHOULD THE DEVICE BECOME AVAILABLE FOR RETURN, THE INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TROCAR TIP WAS BROKEN AND PIECES STILL REMAIN IN PATIENT. THERE WAS NO MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189122 NA LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM STRYKER-ENDOSCOPY LAKELAND 5300 CB12LT UNKNOWN 00885825014438

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other