BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910)

    MDR report key: 3023498 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-02935
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 5, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A NEEDLE THAT BROKE IN THE BODY TOWARDS THE ATTACHMENT END WAS SUBMITTED FOR THIS EVALUATION. A MICROSCOPIC INSPECTION REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILITY. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE.

    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 LAPAROSCOPIC HYSTEROMYOMA RESECTION ON (B)(6)2013 AND SUTURE WAS USED. THE SURGEON CURVED THE NEEDLE PRIOR TO USE. WHEN SEWING THE MYOMETRIUM, THE NEEDLE BROKE AND FELL INTO THE PATIENT. THEN THE SURGEON OPENED THE ABDOMEN TO REMOVE THE NEEDLE FRAGMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125567 COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE, ABSORBABLE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other