BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE** SKIN STAPLER 35 WIDE

    MDR report key: 1932709 · Received December 20, 2010

    Report

    Report Number
    3005075853-2010-07243
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 3, 2010
    Report Date
    May 17, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. WITH THIS INFORMATION, THE MANUFACTURING RELATED RECORDS WERE REVIEWED AND WE WERE UNABLE TO CONFIRM THE COMPLAINT NOR DETERMINE A MANUFACTURING OR DESIGN RELATED CAUSE FOR THE REPORTED EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A C-SECTION PROCEDURE, THE DEVICE MISFIRED. LATER THAT AFTERNOON, THE STAPLES POPPED OUT OF THE PATIENT AND IT WAS NOTICED THAT THE STAPLES WERE NOT FORMED CORRECTLY. THE PATIENT WAS TAKEN BACK INTO THE OPERATING ROOM AND ANOTHER DEVICE WAS USED TO RE-STAPLE THE C-SECTION AREA. UNKNOWN PATIENT CURRENT CONDITION. THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** SKIN STAPLER 35 WIDE SKIN STAPLER GDT ETHICON ENDO-SURGERY, LLC. NA G4U49L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| O UNK.