BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB

    MDR report key: 2304621 · Received February 4, 2008

    Report

    Report Number
    3004028675-2008-00002
    Event Type
    Other
    Date Received
    February 4, 2008
    Date of Event
    December 13, 2007
    Report Date
    February 1, 2008
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) SUBCUTICULAR STAPLE HAS BEEN SUCCESSFULLY USED TO CLOSE ABDOMINAL INCISIONS IN MANY HOSPITALS AROUND THE COUNTRY. NUMEROUS SURGEONS USE IT AS THEIR STANDARD OF CARE. THE ORIGINAL COMPLAINT STATED THE INCISION WAS OVER AN EXISTING SCAR FROM A PREVIOUS SURGERY. IN OUR INVESTIGATION, NO INFORMATION WAS PROVIDED THAT THIS SCAR TISSUE WAS FULLY EXCISED. THE IFU FOR THE (B)(4) STAPLER CLEARLY STATES IT IS CONTRAINDICATED FOR USE IN SCAR TISSUE. OUR REVIEW OF THE INFORMATION PROVIDED SUGGESTS THE OUTCOME IS RELATED TO PREEXISTING SCAR TISSUE IN THE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    AN INCISION CLOSURE OF A MIDLINE TOTAL ABDOMINAL HYSTERECTOMY (TAH) SEPARATED 1-DAY POST-OPERATIVELY REQUIRING SURGICAL INTERVENTION FOR ER-CLOSURE OF THE SKIN UNDER GENERAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSORB SKIN STAPLER GAG INCISIVE SURGICAL, INC. INSORB 25 073601

    Patients

    Seq Age Sex Outcome Treatment
    1 Other