BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM

    MDR report key: 1920573 · Received December 13, 2010

    Report

    Report Number
    3005075853-2010-07024
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 26, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    KOG
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION:

    Additional Manufacturer Narrative · 1

    (B)(4). (DEVICE B): SERIAL = (B)(4); OTHER # = F5W45K (BATCH #); EXP DATE = 07/14/2014, (DEVICE B): MFR DATE 8/14/2009. (DEVICE E): SERIAL = (B)(4); OTHER # = G5XU07 (BATCH #); EXP DATE = 12/25/2014, (DEVICE E): MFR DATE 1/25/2010. (DEVICE F): SERIAL = (B)(4); OTHER # = F5X432 (BATCH #); EXP DATE = 10/10/2014, (DEVICE F): 11/10/2009 (B)(4). DEVICE A ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THREE DEVICES, (B), (C) AND (D), ARRIVED STERILE AND IN GOOD VISUAL CONDITION FROM THE SAME BATCH NUMBER. DEVICE B WAS PULLED OUT AND TESTED FOR FUNCTIONALITY WITH THE RETURNED WASHER AND IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. DEVICE (E) AND (F) ARRIVED STERILE AND IN GOOD VISUAL CONDITION. THE DEVICES WERE PULLED OUT OF THE ORIGINAL PACKAGES TO BE TESTED. THE DEVICES WERE TESTED FOR FUNCTIONALITY WITH THE RETURNED WASHERS AND BOTH DEVICES FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHERS WITHOUT INCIDENT. THE STAPLE LINES WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE FIRED FINE. THE DONUTS WERE INTACT. WHEN A LEAK TEST (AIR & SALINE) WAS DONE, THE LEFT SIDE OF THE ANASTOMOSIS FELL APART. THE ANASTOMOSIS WAS HAND SEWED CLOSED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH** ILS ENDOSCOPIC CURVED INTRALUMINAL STAPLER - 29 MM CIRCULAR STAPLERS KOG ETHICON ENDO-SURGERY, LLC. NA A93048

    Patients

    Seq Age Sex Outcome Treatment
    1