BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB

    MDR report key: 2304619 · Received January 18, 2008

    Report

    Report Number
    3004028675-2007-00002
    Event Type
    Other
    Date Received
    January 18, 2008
    Date of Event
    December 7, 2007
    Report Date
    January 17, 2008
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GAG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSORB SUBCUTICULAR STAPLE HAS BEEN SUCCESSFULLY USED TO CLOSE INCISIONS FOLLOWING HIP IMPLANT SURGERY (HEMIARTHROPLASTY) IN MANY HOSPITALS AROUND THE COUNTRY. NUMEROUS SURGEONS USE IT AS THEIR STANDARD OF CARE. THE OPERATIONAL CONTEXT OF HEMIARTHROPLASTY REQUIRES MULTI-LAYER CLOSURE TO RELIEVE TENSION. ON JULY 26, 2006, INCISIVE SURGICAL'S 510 (K) K061784 WAS CLEARED TO ADD A PRECAUTION TO ITS INSTRUCTIONS FOR USE WHICH READS: "TENSION - PLACEMENT OF SUPPORTING SUTURES OR OTHER CLOSURE AUGMENTATION MAY BE REQUIRED TO ENSURE CLOSURE INTEGRITY WHEN EXCESSIVE TENSION ON THE WOUND EDGE IS OR MAY BE PRESENT, E.G. HIGH-TENSION AREAS, OBESE PATIENTS, EXCISIONS, OR WOUNDS THAT MAY EXPERIENCE SIGNIFICANT SWELLING." THIS INCIDENT OCCURRED FOLLOWING THE SURGEON'S FIRST DAY OF USE OF THE STAPLER. WE DID NOT RECEIVED FURTHER INFORMATION OR THE RETURNED DEVICE. OUR REVIEW OF THE INFORMATION PROVIDED SUGGESTS THE OUTCOME IS RELATED TO HIGH TENSION IN THE OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    AN INCISION CLOSURE OF A HEMIARTHROPLASTY (HIP IMPLANT) SEPARATED POST-OPERATIVELY REQUIRING SURGICAL INTERVENTION FOR RE-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