BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 1599078 · Received February 15, 2010

    Report

    Report Number
    1056128-2010-00003
    Event Type
    Injury
    Date Received
    February 15, 2010
    Date of Event
    January 18, 2010
    Report Date
    February 15, 2010
    Manufacturer
    ASCENT HALTHCARE SOLUTIONS
    Product Code
    NLM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BABCOCK GRASPER WAS NOT RETURNED TO ASCENT HEALTHCARE SOLUTIONS FOR EVALUATION. HOWEVER, PICTURES OF THE COMPLAINT DEVICE WERE PROVIDED AND REVIEWED. NO VISIBLE DAMAGE TO THE DEVICE WHICH MAY HAVE AFFECTED THE FUNCTIONALITY OF THE DEVICE WAS OBSERVED. SINCE THE DEVICE WAS NOT AVAILABLE FOR FUNCTION TESTING, NO ROOT CAUSE COULD BE DETERMINED. HOWEVER, ASCENT'S INSTRUCTIONS FOR USE STATE: "AVOID EXCESSIVE CLAMPING PRESSURE THAT COULD CAUSE DAMAGE TO THE TISSUE." "TO AVOID DAMAGE TO THE PATIENT, TO OPERATOR OR TO INSTRUMENT, BECOME FAMILIAR WITH A SPECIFIC INSTRUMENT AND IT'S CLAMPING OR CUTTING MECHANISM PRIOR TO EMPLOYING IT IN A SURGICAL PROCEDURE." A REVIEW OF THE LOT CONTROL SHEET FOR THE REPORTED DEVICE SERIAL NUMBER INDICATED THAT THE INSTRUMENT PASSED ALL APPLICABLE TESTS AND INSPECTIONS PRIOR TO RELEASE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION PROCEDURE, WHILE GRASPING THE STOMACH WITH THE JAWS OF THE BABCOCK, THE PHYSICIAN CLICKED THE HANDLE OF THE DEVICE ONE CLICK AND THE JAWS PUNCTURED THE STOMACH. THIS HAPPENED TWICE DURING THE PROCEDURE. ACCORDING TO A USER FACILITY MEDWATCH, THE TWO HOLES WERE NOTED ON THE FUNDUS OF THE STOMACH. ONE ALONG THE GREATER CURVATURE AND ONE WAS MORE POSTERIOR. EACH HOLE MEASURED ABOUT A CENTIMETER. THE HOLES WERE REPAIRED WITH AN ENDO STITCH IN TWO LAYERS WITH 0 VICRYL. NO OTHER PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A NLM NLM ASCENT HALTHCARE SOLUTIONS 10BB 681938

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention