BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 45799 · Received October 23, 1996

    Report

    Report Number
    1628808-1996-00084
    Event Type
    Malfunction
    Date Received
    October 23, 1996
    Date of Event
    August 30, 1996
    Report Date
    October 23, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS OF EVALUATION: CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, IT APPEARS AS IF AN ATTEMPT WAS MADE TO FIRE THE INSTRUMENT ACROSS A HARD OBJECT. THIS IS EVIDENCED BY THE VISIBLE DAMAGE TO THE KNIFE AND CARTRIDGE. THE LOCK-OUT WAS RESET ON THE RETURNED CARTRIDGE AND THE INSTRUMENT WAS FIRED WITH THE RETURNED CARTRIDGE. DESPITE THE DAMAGE TO THE CARTRIDGE AND KNIFE, THE INSTRUMENT FIRED AND FORMED THE REMAINING STAPLES AS DESIGNED. ADDITIONALLY, THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND FIRED AND FORMED STAPLES AS DESIGNED ACROSS THE ENTIRE STAPLE LINE WITH NO DIFFICULTIES NOTED. COMMENTS: MFG AND ENGINEERING HAVE BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A BOWEL RESECTION. IT WAS REPORTED THE DEVICE WAS PLACED OVER BOWEL AND FIRED, THE FIRING KNOB ADVANCED ONLY HALFWAY AND JAMMED. THE SURGEON DISENGAGED THE DEVICE AND IT WAS OBSERVED NOT ALL THE STAPLES FIRED. THE ANASTOMOSIS WAS SHORTENED AND THE SURGEON HAND SEWED TO COMPLETE THE PROCEDURE. THERE WAS NO PT CONSEQUENCE. ON 9/26/96 1554 SURGEON CONFIRMED THE INFO AS REPORTED BY THE SALES REP. SURGEON STATED ON THE THIRD FIRING THE INSTRUMENT "LOCKED UP." ONLY HALF OF THE STAPLELINE WAS FIRED WITH ONLY HALF OF THE CUT. THE INSTRUMENT WOULD NOT OPEN, AND TOOK "BRUTE STRENGTH" TO SEPARATE. THE REST OF THE TISSUE WAS HAND SEWED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTER GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other