BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 109654 · Received July 30, 1997

    Report

    Report Number
    1527736-1997-01843
    Event Type
    Malfunction
    Date Received
    July 30, 1997
    Date of Event
    June 5, 1997
    Report Date
    July 2, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH PROXIMATE* LINEAR CUTTER ON 6/5/97 WHILE PERFORMING A BOWEL PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 974164. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CAM POSITION: ENGAGED/DISENGAGED DISENGAGED; CARTRIDGE BATCH NUMBER: K4642W; CARTRIDGE POSITION: LOADED; DRIVERS PRESENT IN CARTRIDGE, PRESENT/3/4 UP; FIRING KNOB POSITION: BACK/PARTIAL, BACK; GAPSPACE PIN CONDITION: GOOD; HOOK LATCH POSITION: OPEN/CLOSED, CLOSED; INSTRUMENT HALVES: JOINED/SEPARATE, JOINED; KNIFE CONDITION: GOOD; STAPLES PRESENT? FORMED/UNFORMED, IN DOWN DRIVERS AND SWING TAB POSITION: LOCKED/UNLOCK LOCKED. FUNCTIONAL TESTS & RESULTS: INSTRUMENT SAFETY LOCKOUT PROPERLY, YES; STAPLES FIRE PROPERLY, YES AND STAPLES FORM PROPERLY, YES. ANALYSIS CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND FIRED AND FORMED STAPLES ACROSS THE ENTIRE STAPLE LINE WITH NO DIFFICULTIES NOTED. THE MFG AND ENGINEER HAS BEEN NOTIFIED OF THE REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT IS REPORTED IN ORDER TO CONTINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A SMALL BOWEL RESECTION WITH ANASTOMOSIS GASTROJEJUNOSTOMY AND GASTROSTOMY PROCEDURE. IT WAS REPORTED THE TLC75 DID NOT STAPLE PROPERLY. A NEW TLC75 WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA K4672E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other