BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG 45 ENDOCUTTER

    MDR report key: 2150666 · Received July 6, 2011

    Report

    Report Number
    3005075853-2011-02774
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSTRUMENT B: BATCH # F5WN0C, EXP DATE: 09/06/2014; MANUFACTURE DATE: 10/06/2009; (SPRING CARTRIDGE LOCKOUT TAB); THE ANALYSIS RESULTS FOUND THAT THE LONG45A DEVICE (A) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT 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. THE ANALYSIS SHOWED THAT THE LONG45A DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITION AND WITH FIVE RELOADS PRESENT. RELOADS C, D, F, AND G WERE RECEIVED FULLY FIRED AND WITH THE LOCKOUT SPRING NORMAL; RELOAD E WAS RECEIVED FULLY FIRED AND WITH THE LOCKOUT SPRING BROKEN. THE DAMAGE TO THE RELOAD LOCKOUT SPRING IS CONSISTENT WITH DAMAGE OBSERVED WHEN ATTEMPTING TO FIRE AN ALREADY SPENT CARTRIDGE. THE RELOAD IS DESIGNED TO LOCK OUT AFTER A PARTIAL OR COMPLETE FIRE TO AVOID RE FIRING A PARTIALLY OR FULLY SPENT RELOAD. FIRING THROUGH THE LOCKOUT MECHANISM CAN BREAK THE DEVICE. FOR MORE INFORMATION PLEASE REFER TO THE INSTRUCTIONS FOR USE. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. THE RELOAD WAS INSTALLED WITHOUT ANY DIFFICULTIES AND DID NOT FELL OUT DURING FUNCTIONAL TESTING. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC RADICAL CYSTECTOMY PROCEDURE TWO DEVICES WERE USED IN THE CASE WITH FIVE CARTRIDGES. THERE WAS SEVERE BLEEDING FROM THE STAPLE LINE, BUT IT IS UNKNOWN IF THE BLEEDING OCCURRED AT ALL FIVE FIRING. THE SURGEON STATED THAT SOME OF THE STAPLES WERE NOT FORMED OR NOT FORMED CORRECTLY. IT IS UNKNOWN HOW THE BLEEDING WAS CONTROLLED. THE PATIENT RECEIVED 4 UNITS OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LONG 45 ENDOCUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention