BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSORB

    MDR report key: 5113832 · Received November 18, 2004

    Report

    Report Number
    3004028675-2004-00001
    Event Type
    Other
    Date Received
    November 18, 2004
    Date of Event
    October 22, 2004
    Report Date
    November 18, 2004
    Manufacturer
    INCISIVE SURGICAL, INC.
    Product Code
    GDT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    STAPLER USED IN CASE HAD BEEN CARRIED BACK TO INCISIVE FOR POST-MARKET SURVEILLANCE SAMPLING. FOLLOWING THE ISSUANCE OF THIS COMPLAINT, THE UNIT WAS DISINFECTED AND EXAMINED. THREE STAPLES REMAINED IN THE UNIT. NO EXTRAORDINARY OBSERVATIONS WERE MADE (THE ASSEMBLY WAS CORRECT, ALL PARTS WERE PRESENT, THE GAPS WERE TYPICAL, A MINOR BEND OCCURRED ON ONE PENETRATOR SECONDARY TIP, TWO SCRAPE MARKS WERE EVIDENT ON THE INSIDE OF THE RECEIVER SURFACE). NONE OF THESE OBSERVATIONS CAN SIGNIFICANTLY EFFECT THE PERFORMANCE OF THE STAPLE. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATIONS. REVIEW OF THE CLINICAL INFORMATION SUGGESTS THE OUTCOME IS RELATED TO: HIGH TENSION, OBESITY, AGE OF PATIENT IS 65 YEARS, AND THE PATIENT HAS CANCER. ACCORDING TO CLINICAL LITERATURE, ALL OF THE ABOVE FACTORS CORRELATE TO DEHISCENCE. THE CONTRAINDICATIONS FOR THE INSORB 20 INCLUDE THE FOLLOWING: "USE OF THE STAPLE ON MORBIDLY OBESE PATIENTS, OR WHEN EXCESSIVE TENSION ON THE WOUND EDGES IS OR WILL BE PRESENT, IS CONTRAINDICATED."

    Description of Event or Problem · 1

    A MIDLINE LAPAROTOMY INCISION ON AN OBESE PATIENT WAS CLOSED ON (B)(6) 2004 WITH APPROX. 17 STAPLES WITHOUT DEEP WOUND SUPPORT. ON THE SECOND POST-OPERATIVE DAY, THE SKIN INCISION DEHISCED. THE WOUND WAS HIGH TENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 INSORB SKIN STAPLER GDT INCISIVE SURGICAL, INC. INSORB 20 043801

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R