BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 110786 · Received August 5, 1997

    Report

    Report Number
    1527736-1997-01893
    Event Type
    Injury
    Date Received
    August 5, 1997
    Date of Event
    June 16, 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

    FACILITY EXPERIENCED AN EVENT WITH PROXIMATE I L S INTRALUMINAL STAPLER ON 6/16/97 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 #974235. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: B/A WASHER PRESENT/CONDITION, PRESENT AND CUT IN; DAMAGED ANVIL/ANVIL SHROUD, DAMAGED GUIDE FACE, DAMAGED KNIFE, DAMAGED STAPLE POCKETS, DAMAGED TROCAR, MISSING PARTS, STAPLES PRESENT/LOCATION, AND TISSUE PRESENT/DESCRIBE, NO; DAMAGED OTHER, NA; AND SERIAL NUMBER, 285. FUNCTIONAL TESTS & RESULTS: 1ST FIRE-SETTING/FORM/HEIGHTS, HIGH B/GOOD; 1ST FIRE-WASHER CUT, INDICATOR RESPONSE, SAFETY RELEASE, 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. UPON RECEIPT OF THE INSTRUMENT, IT WAS NOTED THAT THE INNER CASING WAS CRACKED. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE INSTRUMENT OCCURRED. THE INSTRUMENT WAS RELOADED AND FIRED. DESPITE THE DAMAGE TO THE INSTRUMENT, IT FIRED AND FORMED ALL 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 COTNINUOUSLY IMPROVE THE PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LOW ANTERIOR RESECTION THE CDH29 STAPLES DID NOT FORM PROPERLY, LEAVING A POSTERIOR TEAR IN THE STAPLE LINE. THE SURGEON RESUTURED THE STAPLE LINE, TAKING APPROXIMATELY 2 HOURS TO CLOSE.

    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 K4678J

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other