BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

    MDR report key: 6154812 · Received December 8, 2016

    Report

    Report Number
    3005075853-2016-06911
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 30, 2016
    Report Date
    December 1, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 1/19/2017 . THE ANALYSIS RESULTS OF THE POUCH FOUND THAT ONLY THE BAG WAS RECEIVED FOR ANALYSIS. UPON EVALUATION, THE BAG WAS NOTED TO BE TORN AT THE BOTTOM END (NOT AT THE SEAMS). THE TORN PORTION WAS NOTED STRETCHED. EACH DEVICE IS 100% VISUALLY INSPECTED AT TWO DIFFERENT ASSEMBLY OPERATIONS PRIOR TO SHIPMENT AND DAMAGE OF THIS MAGNITUDE WOULD HAVE BEEN DETECTED DURING THIS INSPECTION. HOWEVER, A POTENTIAL CAUSE OF THE TORN BAG IS ATTEMPT TO REMOVE THE BAG WITH SPECIMEN THROUGH THE TROCAR OR FORCE THE BAG THROUGH THE ACCESS SITE AS THIS MAY LEAD TO BAG RUPTURE AND SPILLAGE OF CONTENTS. THE FOLLOWING OPTIONS ARE RECOMMENDED IN ORDER TO AVOID THIS KIND OF ISSUE: REMOVE THE INSTRUMENT, SPECIMEN BAG, AND TROCAR TOGETHER FORM THE ACCESS SITE (DO NOT PULL THE SLIP KNOT). REMOVE THE INSTRUMENT FROM THE TROCAR, FOLLOWING BY THE SPECIMEN BAG WITH THE TROCAR. REMOVE THE INSTRUMENT, TROCAR AND SPECIMEN BAG SEPARATELY FROM THE ACCESS SITE. IF THE BAG WITH THE SPECIMEN CANNOT BE REMOVED THROUGH THE ACCESS SITE, CAREFULLY ENLARGE THE ACCESS SITE TO FACILITATE EASY BAG REMOVAL. THE BATCH HISTORY RECORD WAS REVIEWED AND NO DEFECTS, NCR¿S OR PROTOCOLS RELATED TO THE COMPLAINT, WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AS THE SURGEONS WHERE TAKING OUT THE POUCH WITH THE GALLBLADDER WITHIN THE BAG BROKE. UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805484 LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA N4LV72

    Patients

    Seq Age Sex Outcome Treatment
    1