BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE 100MM TITANIUM LINEAR CUTTER

    MDR report key: 140387 · Received December 23, 1997

    Report

    Report Number
    1527736-1997-03609
    Event Type
    Malfunction
    Date Received
    December 23, 1997
    Date of Event
    November 27, 1997
    Report Date
    November 28, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED WITH NO LOT IDENTIFICATION. INSTRUMENT TESTED AND MET DESIGN SPEICIFICATIONS. THE HOOK LATCH SHROUD WAS NOT CONNECTED TO THE HOOK LATCH REAR CONNECTION, WHICH DID NOT AFFECT THE INSTRUMENTS FUNCTIONALITY, AND WAS DUE TO AN ASSEMBLY ERROR. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE. 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, K47L7E; CARTRIDGE POSITION, FULLY SEATED; DRIVERS PRESENT IN CARTRIDGE, YES/EXTNEDED; FIRING KNOB POSITION: BACK/PARTIAL, BACK; GAPSPACE PIN CONDITION, GOOD; HOOK LATCH POSITION: OPEN/CLOSED, CLOSED; INSTRUMENT HALVES: JOINED/SEPARATE, NO; KNIFE CONDITION, GOOD; STAPLES PRESENT? FORMED/UNFORMED, NO AND SWING TAB POSITION: LOCKED/UNLOCK, LOCKED. FUNCTIONAL TESTS & RESULTS: INSTRUMENT SAFETY LOCKOUT PROPERLY, YES; STAPLE HEIGHTS CONFORMING, YES; STAPLES FIRE PROPERLY, YES AND STAPLES FORM PROPERLY, YES. ANALYSIS CONCLUSION: BASED ON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION AND FUNCTIONAL TEST, IT WAS CONCLUDED THE INSTRUMENT WAS CONFORMING WITH REGARD TO THE BLADE CUTTING AND THE STAPLES FIRING AND FORMING PROPERLY. THE INSTRUMENT WAS RECEIVED IN GOOD PHYSICAL CONDITION AND WITH THE HOOK LATCH SHROUD NOT CONNECTED TO THE HOOK LATCH AT THE REAR CONNECTION. THIS DID NOT AFFECT THE INSTRUMENT'S FUNCTIONALITY. THE INSTRUMENT WAS EXAMINED AND WAS FOUND TO BE FUNCTIONAL AND WAS THEN RELOADED WITH A RELOAD TEST CARTRIDTE (BATCH # K4772W). THE INSTRUMENT WAS THEN CYCLED, FIRED, AND FORMED ALL STAPLES AND FULLY CUT WITHOUT INCIDENT. THE STAPLES WERE MEASURED AND WERE FOUND TO BE WITHIN SPECIFICATIONS. IT WAS CONCLUDED THAT THE HOOK LATCH SHROUD NOT BEING CONNECTED TO THE HOOK LATCH AT THE REAR CONNECTION WAS DUE TO AN ASSEMBLY ERROR BUT NO CONCLUSION COULD BE RACHED AS TO WHY "THE STAPLES MALFORMED ON THE GASTRIC WALL" DURING SURGERY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOULSY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A GASTRECTOMY (SUB-TOTAL) PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE STAPLES MALFORMED ON THE GASTRIC WALL AND SOME BLEEDING WAS NOTICED. THE SURGEON PLACED OVERSTITCHES TO CLOSE THE TISSUE. THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE 100MM TITANIUM LINEAR CUTTER LINEAR CUTTER GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other