BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 102704 · Received July 2, 1997

    Report

    Report Number
    1527736-1997-01495
    Event Type
    Malfunction
    Date Received
    July 2, 1997
    Date of Event
    May 28, 1997
    Report Date
    July 1, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH PROXIMATE* LINEAR CUTTER ON 5/28/97 WHILE PERFORMING A MISC; WHIPPLES. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973703. 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 NUMBE: NOT RETURNED; CARTRIDGE POSITION: NOT RETURNED; FIRING KNOB POSITION: BACK/PARTIAL, PARTIALLY BACK; HOOK LATCH POSITION: OPEN/CLOSED, CLOSED; INTRUMENT HALVES: JOINED/SEPARATE, JOINED AND KNIFE CONDITION: GOOD. 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. UPON RECEIPT OF THE INSTRUMENT, IT WAS NOTED THAT THE CARTRIDGE WAS NOT RETURNED WITH THE INSTRUMENT. AS THE CARTRIDGE WAS NOT RETURNED, THE INTERACTION BETWEEN THE INSTRUMENT AND CARTRIDGE COULD NOT BE ANALYZED. THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND FIRED AND FORMED STAPLES ACROSS THE ENTIRE STAPLE LINE WITH NO DIFFICULTIES NOTED. THE TEST MEDIA WAS FULLY CUT. MFG AND ENGINEERING HAVE BEEN NOTIFED 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

    THE DEVICE WAS USED DURING A WHIPPLES PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE FIRED BUT DID NOT CUT. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CUTTER LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA K4670D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other