BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** XCEL

    MDR report key: 1822263 · Received September 1, 2010

    Report

    Report Number
    3005075853-2010-05000
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Report Date
    August 30, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). DUCKBILL, LEAK TEST FAILURE. THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED INSIDE ITS ORIGINAL PACKAGE. UPON EVALUATION OF THE DEVICE, THE DUCKBILL WAS FOUND TO BE SLIGHTLY OPEN AT THE SLIT. A LEAK TEST WAS PERFORMED AND THE DEVICE WAS NOTED TO LEAK DURING INSERTION AND REMOVAL OF THE TEST PROBE THROUGH THE DEVICE. A POTENTIAL CAUSE OF THIS FAILURE IS ATTRIBUTED TO MOLDING, COMPONENT TRANSIT, BODILY FLUIDS OR DEBRIS FROM SURGERY. AS EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING THE MANUFACTURING PROCESS, NO CONCLUSION COULD BE REACHED AS TO WHAT MIGHT HAVE CAUSED THE REPORTED EVENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE VALVE DID NOT HOLD THE GAS. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SLING PROCEDURE AT THE BEGINNING OF 2010 FOR STRESS URINARY INCONTINENCE. ON (B)(6)2010, THE PT COMPLAINED OF A STITCH STILL IN THE VAGINA AND SOME DYSPAREUNIA. UPON PHYSICAL EXAM, THE PT WAS FOUND TO HAVE A 1 X 1CM VAGINAL MESH EROSION IN THE LEFT AND RIGHT ANTERIOR VAGINAL WALL AND THE DISTAL VAGINA. THE PT DID HAVE A LEFT BUTTONHOLE DURING THE ORIGINAL SURGERY. THE PT HAD INTERCOURSE TWO WEEKS POST-OPERATIVELY. ON (B)(6)2010, THE PT PRESENTED FOR EXCISION AND REPAIR. MESH WAS EXCISED AT BILATERAL FORNICES AND THE MUCOSA WAS OVERSEWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA F4PR31

    Patients

    Seq Age Sex Outcome Treatment
    1