BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX

    MDR report key: 6378852 · Received March 4, 2017

    Report

    Report Number
    2027111-2017-01379
    Event Type
    Malfunction
    Date Received
    March 4, 2017
    Date of Event
    June 16, 2014
    Report Date
    March 3, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915125714
    PMA / PMN Number
    2
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS TWO COMMON DEVICE NAMES: KGW AND GCJ. INVESTIGATION SUMMARY: THE TROCAR COMPONENT OF THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING CONFIRMED THE DAMAGE TO THE TROCAR SLEEVE. THE TROCAR SLEEVE WAS LIKELY DAMAGED BY ANOTHER DEVICE BEING USED IN THE PROCEDURE. HOWEVER, FROM THE ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL, IT IS UNKNOWN WHAT HAPPENED DURING THE PROCEDURE TO CAUSE THE DAMAGE. THIS REPORT IS BEING FILED AS A RESULT OF A RE-REVIEW OF APPLIED MEDICAL COMPLAINTS RECEIVED BETWEEN JUNE 1, 2014 AND MAY 31, 2016.  THIS RETROSPECTIVE REVIEW WAS ASSOCIATED WITH A QUALITY MANAGEMENT SYSTEM (QMS) COMPLIANCE ACTION PLAN DEVELOPED AND PRESENTED TO FDA TO ADDRESS AN APRIL 10, 2015 WARNING LETTER. APPLIED MEDICAL HAS REVISED ITS MDR REPORTING CRITERIA TO BE MORE CONSERVATIVE AND HAS IMPROVED COMPLAINT HANDLING AND MDR REPORTING PROCESSES. THE REVIEWS ENSURED THAT RECENT REPORTABLE EVENTS WERE APPROPRIATELY IDENTIFIED AND REPORTED TO THE DESIGNATED REGULATORY AUTHORITY(IES). THIS REPORT, WHICH REPRESENTS THE INITIAL AND FINAL REPORTS COMBINED, IS BEING SUBMITTED BASED ON THE FINDINGS OF THAT RETROSPECTIVE REVIEW. IN ACCORDANCE TO 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    ROBOTIC LAPAROSCOPIC PROSTATECTOMY- "NURSE (B)(6) IN THE ROOM STATED THAT THE TROCAR THAT WAS USED FOR THE CAMERA WAS LEAKING PNEUMO. ONCE THEY REMOVED THE TROCAR, THEY NOTICED THE CRACK IN THE SIDES AND REPLACED WITH ANOTHER SINGLE UNIT TROCAR. DR. TEWARI MENTIONED TO THE NURSE THAT IT HAPPENED TWICE PRIOR BUT NO SPECIFIC DATE." PATIENT STATUS - "PATIENT WAS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161268 C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX KGW KGW APPLIED MEDICAL RESOURCES 2 1219664 00607915125714

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI ROBOT