BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE I L S INTRALUMINAL STAPLER

    MDR report key: 96570 · Received June 5, 1997

    Report

    Report Number
    1527736-1997-01153
    Event Type
    Malfunction
    Date Received
    June 5, 1997
    Date of Event
    May 7, 1997
    Report Date
    June 4, 1997
    Manufacturer
    EES-ALBUQUERQUE
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH PROXIMATE I L S INTRALUMINAL STAPLER ON 5/7/97 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 # 972842. 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, NO; DAMAGED GUIDE FACE, NO; DAMAGED KNIFE, NO; DAMAGED OTHER, NO; DAMAGED STAPLE POCKETS, NO; DAMAGED TROCAR, NO; MISSING PARTS, NO; SERIAL NUMBER, 51; 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; INDICATOR RESPONSE, GOOD; SAFETY RELEASE, GOOD AND TROCAR/ANVIL FIT, GOOD. ANALYSIS CONCLUSION: BASED ON THE INFO REC'D AND THE VISUAL AND FUNCTIONAL RESULTS, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RELOADED AND FIRED. IT FIRED AND FORMED ALL THE STAPLES AS DESIGNED WITH NO DIFFICULTIES NOTED. 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 CO'S PRODUCTS.

    Description of Event or Problem · 1

    THE INSTRUMENT WAS USED DURING A LOW ANTERIOR RESECTION. IT WAS REPORTED THE CDH WAS FIRED WITHOUT DIFFICULTY. WHEN THE SURGEON CHECKED THE DONUTS,THEY WERE COMPLETE. WHEN SURGEON CHECKED ANASTOMOSIS, ONLY HALF THE STAPLES WERE FIRED. NO OTHER DETAILS WERE AVAILABLE. RISK MANAGEMENT IS HOLDING THE INSTRUMENT AT THIS TIME. REP IS TO GET IT ON MONDAY. THE SURGEON HAND-SEWED THE ANASTOMOSIS. THE SURGEON DOES NOT USE THIS INSTRUMENT REGULARLY, BUT OR STAFF REPORTED IT WAS USED APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE I L S INTRALUMINAL STAPLER CIRCULAR STAPLERS GAG EES-ALBUQUERQUE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other