BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE SKIN STAPLER 35 WIDE

    MDR report key: 1181743 · Received September 30, 2008

    Report

    Report Number
    3005075853-2008-01992
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSUFFICIENT NOSE WELD. EVALUATION SUMMARY - THE ANALYSIS RESULTS SHOWED THAT ONE INSTRUMENT WAS RETURNED WITH THE NOSE OPEN AND NON-FUNCTIONAL DUE TO INSUFFICIENT NOSE WELD. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, WHEN INTENDING TO USE THE DEVICE IN CLOSING THE INCISION, THE DEVICE MALFUNCTIONED AND DID NOT FORM THE FIRST STAPLE. THE INSTRUMENT WAS THEN REPLACED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE SKIN STAPLER 35 WIDE GDT ETHICON ENDO-SURGERY, LLC NA D4H33U

    Patients

    Seq Age Sex Outcome Treatment
    1