BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 1944670 · Received January 3, 2011

    Report

    Report Number
    3005075853-2011-00029
    Event Type
    Injury
    Date Received
    January 3, 2011
    Report Date
    December 17, 2010
    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
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN AUTOMATED VISION SYSTEM, AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: THE CUSTOMER CONFIRMED THAT THE DONUTS WERE O.K. FURTHER THE CUSTOMER CONFIRMED THAT STAPLES WERE PRESENT. DURING BLUE TESTING HE FIGURED OUT THAT THE ANASTOMOSIS IS LEAKING. HE DECIDED TO CONVERT TO OPEN AS HE WAS OF THE OPINION THAT THE OVERSTITCHING IS BETTER PERFORMED WHEN DOING IT IN AN OPEN SITUS (HE IS NOT SO FAMILIAR WITH ENDOSCOPIC SUTURING AND HE WANTED TO MAKE SURE THAT THE ANASTOMOSIS IS FIXED). PATIENT IS FINE AND HAS ALREADY LEFT THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE, ANASTOMOSIS WAS OPEN DURING BLUE LIQUID CONTROL; DONUTS WERE OK. THEY HAD TO CONVERT THE PROCEDURE TO OPEN AND SUTURED BY HAND. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 G4TU4A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R