BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 99188 · Received June 17, 1997

    Report

    Report Number
    1527736-1997-01308
    Event Type
    Malfunction
    Date Received
    June 17, 1997
    Date of Event
    May 12, 1997
    Report Date
    June 16, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH PROXIMATE* I L S INTRALUMINAL STAPLER ON 5/12/97 WHILE PERFORMING A LOW ANTERIOR RESECTION. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY # 973063. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW: VISUAL INSPECTIONS & RESULTS: B/A WASHER PRESENT/CONDITION, PRESENT/CUT WITH SE ; DAMAGED ANVIL / ANVIL SHROUD, NO ; DAMAGED GUIDE FACE, NO ; DAMAGED KNIFE, YES/NICKS ; DAMAGED OTHER, N/A ; DAMAGED STAPLE POCKETS, NO ; DAMAGED TROCAR, NO ; MISSING PARTS, NO ; SERIAL NUMBER, NO ; STAPLES PRESENT/LOCATION, NO AND TISSUE PRESENT/DESCRIBE, NO. FUNCTIONAL TESTS & RESULTS: 1ST FIRE-SETTING/FORM/HEIGHTS, HIGH B/GOOD ; 1ST FIRE-WASHER CUT, GOOD ; INDICATOR RESPONSE, GOOD ; SAFETY RELEASE, GOOD AND TROCAR / ANVIL FIT, GOOD. 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. IT APPEARS AS IF THE INSTRUMENT MAY NOT HAVE BEEN WAS NOT FIRED THROUGH A COMPLETE FIRING STROKE OR POSSIBLY FIRED OUT OF FIRING RANGE. THIS IS EVIDENCED BY THE BREAKAWAY WASHER BEING RETURNED UNCUT BUT WITH A SLIGHT INDENTATION AROUND THE ENTIRE CIRCUMFERENCE. ADDITIONALLY, IT WAS NOTED THAT THE KNIFE WAS RECEIVED WITH A NICK PRESENT. 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. THE INSTRUMENT WAS RELOADED AND FIRED. IT FIRED AND FORMED THE STAPLES AS DESINGED AROUND THE ENTIRE STAPLE RING WITH AN ACCEPTABLE CUT ON THE TEST MEDIA AND THE BREAKAWAY WASHER. 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 THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CDH33 WAS USED DURING A LOW ANTERIOR RESECTION. THE SURGEON FIRED THE DEVICE BUT WOULD NOT COMPLETELY FIRE AND DID NOT HEAR THE "CRUNCH." THE SURGEON FELT RESISTANCE WHEN FIRING. THE STAPLES CAME OUT BUT DID NOT FORM. THE SURGEON HAD TO RESECT OUT THE STAPLER, ANVIL, AND ABOUT 6-8CM OF TISSUE. A SECOND CDH33 WAS OPENED AND THE CASE COMPLETED WITHOUT DIFFICULTY. THE HOSPITAL REQUESTED THE REP RETURN THE OTHER CDH33 WITH THE SAME LOT NUMBER. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS GAG ETHICON ENDO-SURGERY, INC. NA J43P4G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other