BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH CURVED SCISSORS

    MDR report key: 4925247 · Received July 20, 2015

    Report

    Report Number
    3005075853-2015-04267
    Event Type
    Malfunction
    Date Received
    July 20, 2015
    Report Date
    June 16, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K984240
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT. SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THE SHIPPER BOX THE PRODUCTS WERE SHIPPED IN DAMAGED? NO. IF YES, DOES THE DAMAGE TO THE SHIPPER BOX CORRESPOND TO THE DAMAGE TO PRODUCTS? PLEASE PROVIDE PHOTOGRAPHS IF POSSIBLE. KINDLY CONFIRM AVAILABILITY. NOT AVAILABLE (BUT I SAW THE BOX BEFORE THEY DISCARDED IT AND IT WAS NOT DAMAGED). IS THE PACKAGING STILL AVAILABLE TO RETURN WITH THE DEVICES? YES. IF YES, PLEASE INCLUDE IT WITH THE COMPLAINT SAMPLES. YES. IF NOT, WERE PHOTOS TAKEN THAT CAN BE PROVIDED? THE OPEN 5DCS PACKAGE WAS VISUALLY INSPECTED AND IT WAS CONFIRMED THAT A HOLE WAS PRESENT IN THE FMP LID. THE HOLE APPEARED TO HAVE BEEN CAUSED BY IMPACT OF A SHARP EDGE AT AN ANGLE TO THE LID AND PINCHING THE FMP BETWEEN THE OBJECT AND THE DEVICE. THE PACKAGE WAS IN POOR CONDITION WITH SCRAPES AND WRINKLES AND IT LOOKED LIKE IT HAD BEEN STORED OUTSIDE OF ITS CARTON. DUE TO THE CHARACTERISTICS OF THE DEFECT AND OVERALL CONDITION OF THE PACKAGE, IT IS SUSPECTED THAT THE DAMAGE TO THE PACKAGE OCCURRED OUTSIDE OF THE EES PACKAGING FACILITY. MANUFACTURING CONTROLS INCLUDE 100% VISUAL INSPECTION PLUS RANDOM SAMPLING. THERE ARE NO SHARP EDGES ON ANYTHING AROUND THE PACKAGE INSPECTION AND PACKING AREA. PACKAGES ARE PLACED INTO CARTONS IMMEDIATELY AFTER SEALING AND INSPECTION. COMPLAINT EVENT IS CONFIRMED. EXTERNAL CAUSE. LOT HISTORY RECORDS FOR M4H38V, PRODUCT CODE 5DCS, WERE REVIEWED AND NO PROTOCOLS, DEFECTS, NON-CONFORMANCES OR QUARANTINE NOTED. THE PRODUCT MET ALL IN-PROCESS AND FINISHED GOODS SPECIFICATIONS UPON RELEASE OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE DEVICES IN A PROCEDURE IT WAS NOTED THAT THE STERILE PACKAGING WAS DAMAGED (HOLES). PROCEDURE COMPLETED WITH SAME/LIKE DEVICE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470028 ENDOPATH CURVED SCISSORS ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC. NA M4H75E

    Patients

    Seq Age Sex Outcome Treatment
    1