BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM CURVED

    MDR report key: 4092565 · Received September 16, 2014

    Report

    Report Number
    3005075853-2014-06438
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE IS RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED: WHAT IS THE PATIENT¿S CURRENT CONDITION? WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? WERE ANY UNEXPECTED NOISES HEARD? WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? DID THE WASHER GET CUT INTO TWO (2) PIECES? WERE THERE TWO COMPLETE TISSUE DONUTS? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNFORMED OR MALFORMED STAPLES OBSERVED? HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? WHO FIRED THE DEVICE? ASSISTANT OR THE SURGEON?

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED: WHAT IS THE PATIENT¿S CURRENT CONDITION? PATIENT WENT HOME. WHAT CONFIRMATION DID THE SURGEON RECEIVE THAT THE ANVIL WAS FIRMLY ATTACHED? UNK. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? UNK. WERE ANY UNEXPECTED NOISES HEARD? UNK. WHAT CONFIRMATION WAS RECEIVED INDICATING THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? UNK. DID THE WASHER GET CUT INTO TWO (2) PIECES? UNK. WERE THERE TWO COMPLETE TISSUE DONUTS? UNK. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? UNK. WERE ANY UNFORMED OR MALFORMED STAPLES OBSERVED? UNK. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE FOR THIS PROCEDURE? UNK. WHO FIRED THE DEVICE? ASSISTANT OR THE SURGEON? SURGEON FIRED THE STAPLER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMOID PROCEDURE, THE SURGEON WAS USING THE CDH25A, FIRED THE DEVICE, AND WAS NOT SURE IF DEVICE FIRED STAPLES. THE SURGEON THEN ATTEMPTED TO REMOVE THE DEVICE BUT COULD NOT REMOVE IT FROM THE RECTUM. THE SURGEON CONVERTED TO OPEN PROCEDURE TO PUSH THE STAPLER OUT, AND WITH THE STAPLER WENT A LARGE AMOUNT OF MUCOSA. THE SURGEON RESECTED THE COLON AND HAD TO MOBILIZE AND LIGATE ALL THE WAY UP TO THE TRANSVERSE COLON. THE SURGEON THEN USED THE CDH29A TO PERFORM AN ANASTOMOSIS. WHEN THE ANASTOMOSIS WAS TESTED, THERE WAS A LEAK, SO THE SURGEON USED A SUTURE OF UNKNOWN CODE (ON AN SH NEEDLE) TO OVERSEW THE AREA. WHILE OVERSEWING THE AREA, THE TIP OF THE SUTURE NEEDLE BROKE OFF. THE SURGEON LOOKED FOR THE NEEDLE TIP IN THE RECTUM AND DID NOT FIND IT. AN X-RAY WAS DONE AND NO NEEDLE TIP WAS VISUALIZED ON X-RAY. THE CASE WAS COMPLETED AND CURRENT PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573652 ILS 29MM CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention