BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1880451 · Received October 22, 2010

    Report

    Report Number
    3005075853-2010-06018
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANCILLARY TROCAR THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION, VOID OF STAPLES AND THE BREAKAWAY WASHER UNCUT. THE TIP OF THE ANCILLARY TROCAR WAS LODGED INSIDE THE ANVIL. AFTER FURTHER ANALYSIS, IT WAS NOTED THAT THE LOCKING SPRINGS ON THE ANVIL WERE SCRATCHED. THIS IS CONSISTENT WITH GRASPING THE ANVIL INCORRECTLY. IF TORQUE OR EXCESS FORCE IS APPLIED TO THE ANCILLARY TROCAR, IT MAY CAUSE THE TROCAR TO BREAK. TO DETACH THE ANCILLARY TROCAR, IT SHOULD BE ROTATED 45 DEGREES IN THE ANVIL SHAFT SO THAT THE FINGER NOTCHES ARE PERPENDICULAR TO THE LOCKING SPRINGS (UNLOCKED POSITION). UTILIZING THE FINGER NOTCHES, PULL THE ANCILLARY TROCAR OUT OF THE ANVIL SHAFT. IN ADDITION, IT SHOULD BE NOTED THAT WHEN ATTEMPTING TO REATTACH THE DETACHABLE TROCAR, DO NOT CLAMP ACROSS OR GRIP ON THE LOCKING SPRINGS AS IT WILL NOT RELEASE THE ANCILLARY TROCAR. THE DEVICE WAS TESTED FOR FUNCTIONALITY AT THE HIGH-B SETTING USING A TEST ANVIL AND IT FIRED AND FORMED ALL THE STAPLES, AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 6/8MM AMPLATZER DUCT OCCLUDER (ADO) WAS CHOSEN FOR THE PROCEDURE AND IMPLANTED. HOWEVER, AFTER THE SECOND AORTOGRAM THE ADO WAS FOUND TO HAVE EMBOLIZED TO THE RIGHT PULMONARY ARTERY. THE ADO WAS PERCUTANEOUSLY REMOVED WITH A 6F BIOPTOME AND A 10/12MM ADO WAS IMPLANTED SUCCESSFULLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, WHEN THE PLASTIC TROCAR WAS PLACED IN THE DETACHABLE HEAD OF THE ANVIL AND PLACED INSIDE THE PATIENT BY SUTURES, THE PLASTIC TROCAR SNAPPED OFF AND THE SURGEON HAD TO REMOVE THE SUTURES TO GET THE PRODUCT OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G40940

    Patients

    Seq Age Sex Outcome Treatment
    1