BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CIRCULAR STAPLER

    MDR report key: 4182456 · Received October 17, 2014

    Report

    Report Number
    3005075853-2014-07210
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION RECEIVED: WHAT IS THE PATIENTS CURRENT CONDITION? FINE/WELL. WHEN WAS THE SAFETY RELEASED ON THE DEVICE? PRIOR TO BEING HANDED TO THE SURGEON? AT TIME OF FIRING. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? DR DOES NOT. REMEMBER IF THE FIRING WAS ACROSS THE STAPLE LINE OF THE DISTAL PORTION OF THE BOWEL. HOW DID YOU CONFIRM THE DEVICE WAS FULLY FIRED (SUCH AS CRUNCH, COMPRESSED UNTIL UNABLE TO FIRE FURTHER, ETC.)? DR COULD NOT FIRE HANDLE ANY FURTHER. DR HEARD CRUNCH. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? IF YES, HOW MANY COUNTER-CLOCKWISE REVOLUTIONS WERE USED TO OPEN THE DEVICE? DR OPENED DEVICE MORE THAN INSTRUCTED IN IFU (2-3 FULL TURNS OF NOB). WERE ANY UNFORMED, MALFORMED OR LOOSE STAPLES OBSERVED? IT APPEARED THAT STAPLES WERE MISSING . WHAT DID THE DONUTS LOOK LIKE (COMPLETE RINGS, PARTIAL RINGS,)? GOOD DONUTS WITH FULL RINGS. WAS THE BREAKAWAY WASHER COMPLETELY CUT THROUGH? YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLON RESECTION PROCEDURE, A PORTION OF THE STAPLE LINE WAS INCOMPLETE WITH NO STAPLES VISIBLE. A LEAK TEST WAS PERFORMED AND A LEAK WAS VISIBLE. A THE HOLE IN THE STAPLE LINE REQUIRED THE SURGEON TO OVER SEW THE STAPLE LINE LAPAROSCOPICALLY OR OPEN THE PATIENT AND OVER SEW THE STAPLE LINE WITH AN OPEN TECHNIQUE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661902 PROXIMATE ILS CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1