BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 110781 · Received August 5, 1997

    Report

    Report Number
    1527736-1997-01891
    Event Type
    Injury
    Date Received
    August 5, 1997
    Date of Event
    June 30, 1997
    Report Date
    July 8, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #974212. VISUAL INSPECTIONS & RESULTS: B/A WASHER PRESENT/CONDITION, FULLY CUT; DAMAGED ANVIL / ANVIL SHROUD, NO; DAMAGED GUIDE FACE, NO; DAMAGED KNIFE, YES/GOUGED; DAMAGED OTHER, N/A; DAMAGED STAPLE POCKETS, NO; DAMAGED TROCAR, NO; MISSING PARTS, NO; SERIAL NUMBER, 18; STAPLES PRESENT/LOCATION, NO AND TISSUE PRESENT/DESCRIBE, NO. FUNCTIONAL TESTING & RESULTS: 1ST FIRE-SETTING/FORM/HEIGHTS, HIGH B/GOOOD; 1ST FIRE-WASHER CUT, GOOD; INDICATOR RESPONSE, GOOD; OTHER (NON-CIRC.) STAPLES, PURSE STRING; SAFETY RELEASE, GOOD AND TROCAR / ANVIL FIT, GOOD. ANALYSIS CONCLUSION: BASED ON INFO RECEIVED AND VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED REPORTED INCIDENT. UPON RECIEPT OF INSTRUMENT, IT WAS NOTED THAT KNIFE WAS DAMAED. DUE TO DAMAGE TO KNIFE, IT APPEARS POSSIBLE THAT INSTRUMENT MAY HAVE BEEN FIRED ACROSS A HARD OBJECT. HOWEVER, THIS COULD NOT BE ASCERTAINED. INSTRUMENT WAS CYCLED AND IT PERFORMED AS DESIGNED. INSTRUMENT WAS RELOADED AND FIRED. IT FIRED AND FORMED ALL STAPLES AS DESIGNED WITH NO DIFFICLUTIES NOTED. MFR ENGINEER HAS BEEN NOTIFIED OF REPORTED INCIDENT. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED THE STAPLES DIDN'T FORM PROPERLY. THERE WAS A POSTERIOR TEAR IN THE STAPLE LINE. SURGEON HAD TO SUTURE CLOSE. THE PROCEDURE TIME WAS EXTENDED TO HAND SEW.

    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 K4664T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other