BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROX*ACCESS 55MM

    MDR report key: 1521868 · Received November 5, 2009

    Report

    Report Number
    3005075853-2009-06812
    Event Type
    Injury
    Date Received
    November 5, 2009
    Date of Event
    October 15, 2009
    Report Date
    October 16, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/05/2009: INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    AN ON-SITE ANALYSIS WAS CARRIED OUT IN 2009.DEVICE A WAS IN GOOD VISUAL CONDITIONS AND VOID OF STAPLES. THE DEVICE WAS MANUALLY LOADED WITH STAPLES, AND IT WAS TESTED FOR FUNCTIONALITY. THE DEVICE WAS FIRED, AND IT FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE; THE STAPLE LINE WAS NOTED TO BE COMPLETE. DEVICE B WAS IN GOOD VISUAL CONDITIONS. AFTER FURTHER ANALYSIS, IT WAS NOTED THAT THE DEVICE WAS UNFIRED, AND THE STAPLES WERE PROTRUDING. THE DEVICE WAS TESTED FOR FUNCTIONALITY AND THE DEVICE FIRED AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. POSSIBLE CAUSES FOR PROTRUDING STAPLES MAY BE INTERRUPTION OF THE FIRING CYCLE OR INADVERTENT ACTIVATION OF THE FIRING TRIGGER RESULTING IN THE STAPLES PROTRUDING FROM THE CARTRIDGE OR DEPLOYING NOT FULLY FORMED. IN ADDITION, CAUTION SHOULD BE TAKEN BEFORE FIRING TO ENSURE THE RETAINING PIN IS SEATED IN THE ANVIL. IF THE PIN IS NOT PROPERLY POSITIONED, STAPLES MAY NOT FORM PROPERLY RESULTING IN LEAKAGE OR DISRUPTION OF THE STAPLE LINE. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. 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 SIGMOID COLON RESECTION, THE SECOND DEVICE USED DID NOT STAPLE. THE FIRST DEVICE USED FIRED AND STAPLED PROPERLY, HOWEVER THE ATTEMPT TO REMOVE THE POLYP WAS UNSUCCESSFUL AND WAS NOT RETRIEVED. THE SURGEON BELIEVES THE STAPLE LINE WAS RIGHT ON IT BUT NOT ENOUGH TO RETRIEVE THE SPECIMEN. ADDITIONAL MOBILIZATION WAS PERFORMED AND THE SECOND DEVICE WAS USED, BUT DID NOT STAPLE. THE AREA WAS WIDE OPEN AND THE EEA DEVICE WAS VISIBLE. THE SURGEON HAND SUTURED THE AREA, CREATED ANOTHER PURSE STRING AND COMPLETED THE USE OF A DEVICE FROM THE RECTAL AREA UP. A TEMPORARY COLOSTOMY WAS PERFORMED. THE OR TIME WAS EXTENDED BY 3 HOURS. EES RISK MANAGER SPOKE WITH THE CONTACT AT THE FACILITY: "CONTACT INDICATED THE HOSPITAL WOULD LIKE AN ONSITE ANALYSIS OF THE DEVICE AS THE SURGEON DOES NOT WANT IT SHIPPED BACK TO THE MANUFACTURER. SHE INDICATED THE PATIENT IS DOING WELL AND DID RECEIVE A TEMPORARY COLOSTOMY THAT WILL BE REVERSED. I INDICATED I WOULD SPEAK WITH THE APPROPRIATE ENGINEER TO GET POTENTIAL DATES FOR THE INSPECTION AND GET BACK TO HER."

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). INFO WAS PROVIDED TO THE MFR BY THE VAD COORDINATOR, THAT DUE TO BLACK DUST AND CONFIRMED BEARING WEAR VIA FILTER ANALYSIS WHICH REVEALED COPPER, AN INDICATOR OF BEARING WEAR, A DECISION WAS MADE TO EXCHANGE THE PT'S LVAD WITH ANOTHER LVAD. THE PUMP WAS EXCHANGED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROX*ACCESS 55MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA C4FX1W

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention