BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 24390794 · Received February 19, 2026

    Report

    Report Number
    0001056128-2026-00012
    Event Type
    Malfunction
    Date Received
    February 19, 2026
    Date of Event
    January 1, 2026
    Report Date
    March 9, 2026
    Manufacturer
    STRYKER-ENDOSCOPY LAKELAND 5300
    Product Code
    NLM
    UDI-DI
    00885825014438
    PMA / PMN Number
    K201511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION, INSPECTION WAS UNABLE TO BE PERFORMED. A REVIEW OF THE DHR SUPPORTS THAT THE DEVICE MET ALL INSPECTION AND TEST CRITERIA PRIOR TO RELEASE FROM STRYKER. THE REPORTED EVENT COULD BE ATTRIBUTED TO: - EXCESSIVE FORCE APPLIED - CONTACT WITH HARD OBJECT OR OTHER IMPROPER HANDLING - INSUFFICIENT STRUCTURAL INTEGRITY - SHIPPING/HANDLING DAMAGE OR EXTREME CONDITIONS POST DISTRIBUTION FROM STRYKER'S SUSTAINABILITY SOLUTIONS. 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 TIP OF THE TROCAR BROKE OFF INSIDE OF THE PATIENT. AS REPORTED, THERE TROCAR SLEEVES WERE REPROCESSED BY STRYKER SUSTAINABILITY SOLUTIONS. IT IS UNKNOWN HOW MANY TIMES THIS DEVICE WAS REPROCESSED. IT WAS REPORTED THAT PIECES OF THE DEVICE FELL INTO THE PATIENT AND WERE ABLE TO BE RETRIEVED. A LARGER INCISION WAS NOT MADE TO RETRIEVE THE PIECES AND AN X-RAY WAS NOT USED TO LOCATE THE PIECES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE TROCAR BROKE OFF INSIDE OF THE PATIENT. AS REPORTED, THERE TROCAR SLEEVES WERE REPROCESSED BY STRYKER SUSTAINABILITY SOLUTIONS. IT IS UNKNOWN HOW MANY TIMES THIS DEVICE WAS REPROCESSED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION. NO 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
    452797 NA LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM STRYKER-ENDOSCOPY LAKELAND 5300 16376102 00885825014438

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female