BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHICON LAPAROSCOPIC INSTRUMENT

    MDR report key: 3089490 · Received April 19, 2004

    Report

    Report Number
    1056128-2004-00001
    Event Type
    Malfunction
    Date Received
    April 19, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 8, 2004
    Manufacturer
    VANGUARD MEDICAL CONCEPTS, INC
    Product Code
    GEN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ETHICON 5MM BABCOCK GRASPER WAS RECEIVED BY VANGUARD MEDICAL CONCEPT'S QUALITY ASSURANCE DEPARTMENT. THIS INSTRUMENT WAS ALLEGED TO HAVE THE TEFLON COATING MISSING FROM THE DEVICE SHAFT. AN INVESTIGATION WAS CONDUCTED BY THE ENGINEERING DEPARTMENT TO ESTABLISH POSSIBLE REASONS FOR THIS REPORT. THE GRASPER WAS VISUALLY EXAMINED AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. TO DETERMINE WHETHER THE SHEATH WAS PLACED BY VANGUARD AT ANY TIME, THE THICKNESS OF THE REMAINING SHEATH PORTION ON THE SHAFT NEAR THE HANDLE WAS MEASURED AND COMPARED TO THE THICKNESS OF ANOTHER REPROCESSED INSTRUMENT (EACH TIME THE HEAT SHRINK IS REMOVED FROM THE DEVICE, THERE IS ANOTHER LAYER LEFT ON THAT SMALL PORTION). THE THICKNESS OF THE SHEATH ON THE GRASPER IN QUESTION MEASURED .0085" WHILE THE THICKNESS OF THE SHEATH ON ANOTHER VANGUARD REPROCESSED GRASPER MEASURED .0175. THIS INDICATES THAT THE DEVICE RETURNED DID NOT HAVE THE TWO LAYERS OF THE TEFLON COATING ONE WOULD EXPECT TO REMAIN NEAR THE DEVICE HANDLE. IN ADDITION, THE TWO SEPARATE LAYERS OF TUBING PRESENT ON THE OTHER REPROCESSED INSTRUMENT WERE PEELED AWAY FROM EACH OTHER. THIS INCIDENT IS THE RESULT OF AN OPERATOR OVERSIGHT THAT WAS NOT DETECTED.

    Description of Event or Problem · 1

    AN ETHICON BABCOCK GRASPER REPROCESSED BY VANGUARD WAS SENT TO THE HOSPITAL WITHOUT THE TEFLON COATING ON THE SHAFT. NO PATIENT INJURY WAS REPORTED. AN ANALYSIS OF THE DEVICE WAS CONDUCTED BY ENGINEERING CONFIRMED THE ABSENCE OF THE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON LAPAROSCOPIC INSTRUMENT BABCOCK GRASPER GEN VANGUARD MEDICAL CONCEPTS, INC 588 406634

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK