BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE LINEAR CUTTER

    MDR report key: 96610 · Received June 5, 1997

    Report

    Report Number
    1527736-1997-01165
    Event Type
    Malfunction
    Date Received
    June 5, 1997
    Report Date
    June 5, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH PROXIMATE LINEAR CUTTER ON WHILE PERFORMING A UNK PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973312. 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, NOT RETURNED; CARTRIDGE POSITION, NOT RETURNED; DRIVERS PRESENT IN CARTRIDGE, NA; FIRING KNOB POSITION: BACK/PARTIAL, BACK; GAPSPACE PIN CONDITION, NA; HOOK LATCH POSITION: OPEN/CLOSED, CLOSED; INSTRUMENT HALVES: JOINED/SEPARATE, JOINED; KNIFE CONDITION, NICKED AND BOWED; STAPLES PRESENT? FORMED/UNFORMED, NONE; AND SWING TAB POSITION: LOCKED/UNLOCK, NA. FUNCTIONAL TESTS & RESULTS: INSTRUMENT SAFETY LOCKOUT PROPERLY, STAPLES FIRE PROPERLY, AND STAPLES FORM PROPERLY, YES; AND STAPLE HEIGHTS CONFORMING, NA. 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. AS THE CARTRIDGE WAS NOT RECEIVED WITH THE INSTRUMENT, THE INTERACTION BETWEEN THE INSTRUMENT AND CARTRIDGE COULD NOT BE ANLAYZED. HOWEVER, IT WAS NOTED THAT THE KNIFE OF THE INSTRUMENT WAS NICKED AND BOWED. DUE TO THE DAMAGE TO THE KNIFE, IT APPEARS POSSIBLE THAT AN ATTEMPT MAY HAVE BEEN MADE TO FIRE THE INSTRUMENT ACROSS A HARD OBJECT SUCH AS A CLIP. ADDITIONALLY, IT WAS NOTED THAT THE INSTRUMENT WAS RECEIVED WITH THE LUBRICATION PARTIALLY STRIPPED FROM THE INSTRUMENT. IT COULD NOT BE DETERMINED IF THE LUBRICATION HAD BEEN STRIPPED BEFORE, DURING OR AFTER SURGERY. THE INSTRUMENT WAS FIRED WITH A RELOAD CARTRIDGE AND IT FIRED AND FORMED THE STAPLES AS DESIGNED. THE MFG 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

    THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE DEVICE WOULD NOT FIRE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other