BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8XX2, GELPORT 120MM

    MDR report key: 6055865 · Received October 25, 2016

    Report

    Report Number
    2027111-2016-00734
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    September 28, 2016
    Report Date
    February 22, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915118303
    PMA / PMN Number
    K014047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FOLLOW-UP REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE. 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. 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, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    HAND ASSISTED LAPAROSCOPIC TOTAL COLECTOMY COMPLETION- "DR. (B)(6), COLORECTAL SURGEON AT (B)(6) HOSPITAL, WAS PERFORMING A HAND ASSISTED LAPAROSCOPIC TOTAL COLECTOMY PROCEDURE ON (B)(6) 2016 WITH THE ASSISTANCE OF COLORECTAL RESIDENT (B)(6). THE CASE STARTED AT 12:37PM. DR. (B)(6) PLACED THE GELPORT IN A PFANNENSTIEL INCISION, ONE 10MM SUPER UMBILICAL PORT, AND TWO 5MM ANCILLARY PORTS AND PERFORMED HIS HAND ASSISTED DISSECTION AND MOBILIZATION OF THE DESCENDING COLON, SPLEENIC FLEXTURE, TRANSVERSE COLON, HEPATIC FLEXTURE, AND ASCENDING COLON. HE REMOVED THE GELSEAL CAP AND REMOVED THE DISSECTED COLON SPECIMEN AND PERFORMED HIS ANASTOMOSIS AND COMPLETION INTRACORPOREALLY THROUGH THE ALEXIS WOUND RETRACTOR PORTION OF THE GELPORT. HE PLACED THE GELSEAL CAP ON THE ALEXIS AT APPROXIMATELY 2:47PM TO REINSUFLATE AND FINISH HIS PROCEDURE. THE CLEAR PLASTIC SHEATH OF THE GELPORT RIPPED IN THE MIDDLE REGION, SEPERATING THE GREEN PLACEMENT RING AND RIGID RETRACTION RING. DR. (B)(6) SAID HE WAS NOT IN CONTACT OR MANIPULATING THE GELPORT OR ALEXIS SHEATH DURING THE TIME IT RIPPED. THE TWO PIECES OF THE GELPORT WERE REMOVED AND A NEW GELPORT WAS OPENED TO COMPLETE THE PROCEDURE. DR. (B)(6) USES THE GELPORT FOR ALL OF HIS HALS COLECTOMY PROCEDURES. HE SAID HE HAS EXPERIENCED THE SHEATH RIPPING 1 TO 2 TIMES EACH YEAR SINCE HE BEGAN USING. OTHER INSTRUMENTS INVOLVED IN PROCEDURE: 10MM STORZ CAMERA, 5MM LIGASURE, 11MM KBB HASSON, 2 5MM EXCEL TROCARS, VICRYL SUTURES, ANASTOMOSIS STAPLER, SCALPEL. CIRCULATING NURSE: (B)(6). (B)(6), RESOURCE NURSE FOR THE SOUTH OR WAS MADE AWARE OF THE EVENT. (B)(6) FILLED OUT A MEDICAL DEVICE FAILURE FORM. THE CUSTOMER WOULD LIKE A NO CHARGE REPLACEMENT OF THE GELPORT THAT MALFUNCTIONED. THEIR CORPORATE TEAM WOULD LIKE TO HANDLE SENDING IN THE FORM. APPLIED ALS BRIDGET FONKE WAS IN ROOM DURING TIME OF THE EVENT."TYPE OF INTERVENTION: "OPEN A NEW GELPORT FOR THE SURGEON TO COMPLETE THE PROCEDURE ."PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704927 C8XX2, GELPORT 120MM GCJ GCJ APPLIED MEDICAL RESOURCES C8XX2 1268742 00607915118303

    Patients

    Seq Age Sex Outcome Treatment
    1