BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PNEUMOPERITONEUM NDL

    MDR report key: 1830304 · Received September 10, 2010

    Report

    Report Number
    3005075853-2010-05191
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FDP
    PMA / PMN Number
    K910875
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSTRUMENT WAS RETURNED INTACT FOR ANALYSIS WITH A SYRINGE FULL OF SALINE ATTACHED TO THE LUER LOCK OF THE DEVICE. BASED UPON THE INQUIRY INFORMATION RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED, THE DEVICE WAS BLOCKED BY EXCESS ADHESIVE FROM MANUFACTURING. 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 ASSISTED VAGINAL HYSTERECTOMY PROCEDURE, FLUID WAS NOT ABLE TO BE PASSED THROUGH THE NEEDLE FROM THE SYRINGE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PNEUMOPERITONEUM NDL PNEUMOPERITONEUM NDL FDP ETHICON ENDO-SURGERY, LLC. NA G4TF11

    Patients

    Seq Age Sex Outcome Treatment
    1