BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 19160764 · Received April 22, 2024

    Report

    Report Number
    0001056128-2024-00040
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    March 27, 2024
    Report Date
    April 22, 2024
    Manufacturer
    STRYKER-ENDOSCOPY LAKELAND 5300
    Product Code
    NLM
    UDI-DI
    00885825014193
    PMA / PMN Number
    K201511
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR EVALUATION. AS THE COMPLAINT DEVICE WAS NOT RETURNED, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED AND THE REPORTED EVENT COULD NOT BE CONFIRMED. NO DEVICE INFORMATION WAS REPORTED AND THE CUSTOMER DID NOT REPORT LOT # OR SERIAL # INFORMATION. THEREFORE, THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VERIFIED. 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 THE INSTRUCTIONS FOR USE (IFU) STATE: - THE REPROCESSED ENDOSCOPIC TROCARS AND SLEEVES HAVE APPLICATIONS IN ABDOMINAL, THORACIC, AND GYNECOLOGIC MINIMALLY INVASIVE SURGICAL PROCEDURES TO ESTABLISH A PATH OF ENTRY FOR ENDOSCOPIC INSTRUMENTS. THE BLADELESS TROCARS MAY BE USED WITH OR WITHOUT VISUALIZATION FOR PRIMARY AND SECONDARY INSERTIONS. WARNINGS - THESE INSTRUMENTS ARE ONLY INTENDED FOR USE BY INDIVIDUALS WITH ADEQUATE TRAINING AND FAMILIARITY WITH MINIMALLY INVASIVE TECHNIQUES. FOR FURTHER INFORMATION ABOUT TECHNIQUES, COMPLICATIONS AND HAZARDS, CONSULT THE MEDICAL LITERATURE. - PRIOR TO USE, READ AND FOLLOW THE INSTRUCTIONS OF THIS INSERT AS WELL AS THOSE OF THE INSTRUMENTS AND ACCESSORIES TO BE USED DURING THE PROCEDURE. DAMAGE TO THE INSTRUMENT CAN LEAD TO PATIENT INJURIES. ALWAYS INSPECT INSTRUMENT CAREFULLY FOR OVERALL INTEGRITY BEFORE USE. DIRECTIONS FOR USE - 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 TROCAR CAN BE ASSEMBLED BY INSERTING THE OBTURATOR INTO THE CANNULA SLEEVE UNTIL THEY LOCK SECURELY TOGETHER. 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 THE CLEAR TIP AT THE END OF THE COMPLAINT DEVICE BROKE OFF INTO THE PATIENT AND, ALTHOUGH THE TEAM DID THEIR DID DILIGENCE IN THE OR TO LOOK FOR IT, IT WAS NOT IDENTIFIED VIA ULTRASOUND UNTIL AFTER THE PATIENT LEFT THE OR. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS BROUGHT BACK INTO THE OR A FEW DAYS LATER TO REMOVE THE PIECE DURING A SECOND SURGERY. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IS NOT AWARE OF THE EXTENDED PROCEDURE DURATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189211 NA LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED NLM STRYKER-ENDOSCOPY LAKELAND 5300 B5LT 00885825014193

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention