BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 2833058 · Received November 15, 2012

    Report

    Report Number
    2210968-2012-07348
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE EVALUATION REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY A SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILE FAILURE. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE. IN ORDER TO AVOID THIS KIND OF DAMAGE THE PACKAGE INSERT CAUTIONS: TO AVOID DAMAGING NEEDLE POINTS AND SWAGE AREAS, GRASP THE NEEDLE IN AN AREA ONE-THIRD (1/3) TO ONE-HALF (1/2) OF THE DISTANCE FROM THE SWAGED END TO THE POINT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL LAPAROSCOPIC HYSTERECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE PERFORMING THE SUBCUTICULAR CLOSURE THE NEEDLE BROKE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1