BEUDAMED
    FDA Adverse Event Summary report: N

    12X150MM KII OPTICAL ACCESS SYSTEM NON-THREADED

    MDR report key: 2222833 · Received July 8, 2011

    Report

    Report Number
    2027111-2011-00067
    Date Received
    July 8, 2011
    Date of Event
    April 29, 2011
    Report Date
    July 8, 2011
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE INCIDENT DEVICE WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE CAUSE AND FAILURE MODE OF THE INCIDENT. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT REVEALS NO UNUSUAL EVENTS DURING CONSTRUCTION; THE LOT PASSED ALL QUALITY INSPECTIONS. HOWEVER, CLINICAL DEVELOPMENT WAS CONTACTED IN REGARDS TO THIS CER TO VERIFY THAT A DA VINCI SURGICAL ROBOTIC SYSTEM AND CLAMP VALIDATED FOR APPLIED MEDICAL TROCAR PRODUCTS WAS USED DURING THE TIME OF THE EVENT. IT WAS CONFIRMED THAT A DA VINCI SYSTEM WAS USED; HOWEVER, THE PRODUCT WAS ATTACHED WITH A CLAMP VALIDATED FOR ETHICON PRODUCTS. THE ETHICON CLAMP HAS NOT BEEN VALIDATED FOR USE WITH APPLIED MEDICAL TROCAR PRODUCTS. NON-VALIDATED CLAMPS MAY CAUSE DAMAGE TO APPLIED PRODUCTS. APPLIED RECOMMENDS REVIEW OF THE INTUITIVE SURGICAL, INC.'S (DA VINCI ROBOT MANUFACTURER) INSTRUMENTS AND ACCESSORIES TO UNDERSTAND WHICH APPLIED MEDICAL TROCARS HAVE BEEN VALIDATED FOR USE WITH THE DA VINCI ROBOT AND THE CORRESPONDING ADAPTERS. INTUITIVE SURGICAL, INC. SUPPLIES A VALIDATED MOUNT (MODEL# 371528) FOR APPLIED MEDICAL NON-THREADED TROCAR MODELS. THIS DOCUMENT REPRESENTS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    INCIDENT AS REPORTED: MINIMALLY INVASIVE DAVINCI ASSISTED CORONARY ARTERY BYPASS - "THE TROCAR WAS USED AS THE CAMERA PORT AND WAS PLACED IN BETWEEN THE RIBS. WHILE USING THE DAVINCI, DR. (B)(6) TORQUED ON THE TROCAR AGAINST THE RIB AND THE TROCAR BROKE. A PIECE OF THE DISTAL END OF THE CANNULA BROKE OFF AND FELL INTO THE PATIENT, THEN THE CANNULA DEVELOPED A FRACTURE RUNNING UP THE LENGTH OF THE CANNULA. THE NURSES SWITCH THE BROKEN CANNULA FOR A NEW C0R30. THIS IS THE SECOND TIME THIS HAS HAPPENED WITH THIS SURGEON. DR. (B)(6) ENTERED THE CASE AND SPENT AN HOUR SEARCHING AND FINDING THE BROKEN PIECES OF THE TROCAR. THEY BELIEVE THAT THEY GOT ALL OF THE PIECES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X150MM KII OPTICAL ACCESS SYSTEM NON-THREADED NONE GCJ APPLIED MEDICAL C0R30 1127402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DAVINCI CAMERA