BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1811558 · Received August 23, 2010

    Report

    Report Number
    3005075853-2010-04783
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 27, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. NO DEVICE RETURNING; ADDITIONAL INFORMATION: THE REP ALSO INSPECTED THE FIRST STAPLER AND THERE WERE NO DONUTS AND NO STAPLES ON MAYO STAND. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN SIGMOID COLECTOMY PROCEDURE, THE FIRST DEVICE WAS FIRED BY A RESIDENT AND IT CUT BUT DID NOT STAPLE. THE RESIDENT CLAIMED THEY WERE NOT ABLE TO FIRE THE STAPLER ALL THE WAY WHERE THEY COULD HEAR THE CRUNCH. THE REP WAS THEN PULLED INTO THE ROOM AND ANSWERED QUESTIONS AND WENT OVER THE IFU PRIOR TO A SECOND DEVICE BEING FIRED. PRIOR TO FIRING A SECOND DEVICE, THE CIRCULATING NURSE PUT GLOVES ON AND WAS ABLE TO CLOSE THE FIRST STAPLER WITHOUT ISSUE. A SECOND DEVICE WAS PULLED. WHILE PREPARING FOR THE SECOND ANASTOMOSIS WITH A SECOND DEVICE, THE REP SAW THE UNFORMED STAPLES IN THE PELVIC FROM THE FIRST DEVICE. THE SECOND DEVICE WAS PREPPED AND FIRED; THE DONUTS WERE INSPECTED. THE DISTAL DONUTS WERE PERFECT; THE PROXIMAL DONUTS WERE HALF FORMED. WHEN THE REP LOOKED AT THE PIECE OF DONUT, IT WAS 1/3 OF WHAT IT SHOULD BE. THE SUTURE WAS LOOSE. WHEN IT WAS TESTED WITH AIR, IT LEAKED. THE PROCEDURE HAD NOT BEEN COMPLETED WHEN THE REP DEPARTED. NO DEVICE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1