BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 20529084 · Received October 24, 2024

    Report

    Report Number
    0001056128-2024-00091
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    September 25, 2024
    Report Date
    October 24, 2024
    Manufacturer
    STRYKER-ENDOSCOPY LAKELAND 5300
    Product Code
    NLM
    UDI-DI
    00885825020897
    PMA / PMN Number
    K201511
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE FACILITY STATED THE DEVICE IS UNABLE TO BE RETURNED. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, PHYSICAL INSPECTION OF THE DEVICE WAS UNABLE TO BE PERFORMED. HOWEVER, THE COMPLAINANT PROVIDED PHOTOGRAPHIC EVIDENCE OF THE REPORTED EVENT THAT WAS EVALUATED. THEREFORE, THE REPORTED EVENT WILL BE CONFIRMED. A REVIEW OF THE DHR COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT REPORTED. STRYKER PROCEDURE(S) SUPPORT(S) THAT THE DEVICE WAS UNLIKELY TO HAVE BEEN RELEASED FROM STRYKER WITH THE REPORTED FAILURE MODE. THE REPORTED EVENT COULD BE ATTRIBUTED TO: - EXCESSIVE FORCE APPLIED - CONTACT WITH HARD OBJECT OR OTHER IMPROPER HANDLING - ACTIVATED ELECTROSURGICAL INSTRUMENT MELTS PART OF DEVICE - INSUFFICIENT STRUCTURAL INTEGRITY THE INSTRUCTIONS FOR USE (IFU) STATE: - DAMAGE TO THE INSTRUMENT CAN LEAD TO PATIENT INJURIES. ALWAYS INSPECT INSTRUMENT CAREFULLY FOR OVERALL INTEGRITY BEFORE USE. - DO NOT USE EXCESSIVE FORCE. - CAREFUL HANDLING OF INSTRUMENTS IS NECESSARY TO AVOID DAMAGE OR BREAKAGE. - 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. - A COMPREHENSIVE UNDERSTANDING OF THE PRINCIPLES AND TECHNIQUES INVOLVED IN LASER, ELECTROSURGICAL, AND ULTRASONIC PROCEDURES IS ESSENTIAL TO AVOID SHOCK AND BURN HAZARDS TO BOTH PATIENT AND MEDICAL PERSONNEL AND DAMAGE TO THE DEVICE OR OTHER MEDICAL INSTRUMENTS. 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 HAD A BROKEN TIP. AS REPORTED, THE MISSING PART COULD NOT BE FOUND ON X-RAY AND THE SURGEON DID NOT NOTICE IF THE BROKEN TIP WAS ALREADY THERE BEFORE THE INTRODUCTION. NO OTHER INFORMATION WAS PROVIDED REGARDING PATIENT INJURY, 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
    1772160 NA LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM STRYKER-ENDOSCOPY LAKELAND 5300 B12LT UNKNOWN 00885825020897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention