BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCAR SLEEVE 12/110MM THREADED WITH TAP

    MDR report key: 7973734 · Received October 17, 2018

    Report

    Report Number
    9610612-2018-00472
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Report Date
    November 7, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    GCI
    PMA / PMN Number
    K101937
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: DATE OF EVENT: UNKNOWN. THE INVESTIGATION WAS CARRIED OUT BY THE RESPONSIBLE Q-COORDINATOR OF THE PRODUCTION PLANT. THE TROCAR IS ACCORDING TO THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 0

    ADDITIONAL EVENT DETAILS RECEIVED ON (B)(6) 2018.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE INSTRUMENTS WERE DAMAGED WHILE WORKING WITH THE TROCAR, PARTS OF THE DEVICE CAME LOOSE AND FALL INTO THE ABDOMEN. SURGICAL DELAY LONGER THAN 15 MINUTES REPORTED. LEADING MATERIAL: EK036R, TROCAR SLEEVE 12/110MM THREADED WITH TAP. INVOLVED COMPONENT: STORZ INSTRUMENT. BOTH ARTICLES ARE AVAILABLE. UPDATED INFORMATION: ONLY THE TROCAR WAS RECEIVED. THERE WAS NO FOREIGN INSTRUMENT WITH IT. ADDITIONAL PATIENT OUTCOME AND MEDICAL INTERVENTION INFORMATION HAS BEEN REQUESTED AND WAS INFORMED THAT WHEN THE INFORMATION BECOMES AVAILABLE IT WILL BE FORWARDED OVER.

    Description of Event or Problem · 0

    AFTER FURTHER CONSULTATION WITH THE REP, NO FRAGMENTS HAD TO BE RETRIEVED. THERE WAS ONLY A SHORT TIME OF SURGERY DELAY, SO THE PATIENT WAS WELL AND NO FURTHER MEASURES WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816248 TROCAR SLEEVE 12/110MM THREADED WITH TAP ENDOSCOPY GCI AESCULAP AG EK036R 52406645

    Patients

    Seq Age Sex Outcome Treatment
    1 Other