BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C0R50, 12X130 KII BALLOON BLNT TIP 6/BX

    MDR report key: 6372209 · Received March 2, 2017

    Report

    Report Number
    2027111-2017-01233
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    November 25, 2015
    Report Date
    March 2, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915116460
    PMA / PMN Number
    18
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. ENGINEERING ATTEMPTED TO INFLATE THE BALLOON AND PERFORM A BALLOON LEAK TEST. ENGINEERING WAS UNABLE TO SUCCESSFULLY COMPLETE THIS TEST CONFIRMING THE CUSTOMER EXPERIENCE. THE ROOT CAUSE OF THE EVENT IS LIKELY A COMBINATION OF DAMAGE FROM INSTRUMENTS AND LIPID EXPOSURE. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS. 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 WITH 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-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY. "THIS IS A COMPLAINT FROM THE MARKET. ADMINISTRATIVE NO. (B)(4). PLEASE REFER TO THE COMPLAINT SHEET FOR INVESTIGATION." COMPLAINT SHEET - "THE BALLOON WOULD DEFLATE DURING A PROCEDURE. INSIDE OF THE CANNULA SEEMED TO BE SHAVED. ADDITIONAL INFORMATION GAINED ON (B)(6) 2015 -- PROCEDURE: ROBOTIC-ASSISTED LAPAROSCOPIC RADICAL PROSTATECTOMY. COMBINED INSTRUMENT: DAVINCI. NO EXCESSIVE FORCE WAS APPLIED TO THE TROCAR IN ITS INSERTION INTO THE BODY. IT IS POSSIBLE THE SCOPE ATTACHED TO A DAVINCI ARM DAMAGED THE INSIDE OF THE CANNULA BY LEVERAGE WHEN INSERTED/WITHDRAWN INTO/FROM THE CANNULA. THE EVENT UNIT WAS RETURNED TO OLYMPUS AND VISUALLY INSPECTED. THE SLEEVE WAS FOUND TO BE HEAVILY CRACKED. THE CRACKED PORTION OF THE SLEEVE WAS PARTIALLY PROTRUDING INWARDS. THE UNIT WILL BE RETURNED TO AMR FOR FURTHER EVALUATION. ADMIN# (B)(4)." PATIENT STATUS- NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154698 C0R50, 12X130 KII BALLOON BLNT TIP 6/BX GCJ GCJ APPLIED MEDICAL RESOURCES 18 1248563 00607915116460

    Patients

    Seq Age Sex Outcome Treatment
    1