BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GYNECOLOGY DISPOSABL

    MDR report key: 2003143 · Received February 28, 2011

    Report

    Report Number
    3003604053-2011-00002
    Event Type
    Malfunction
    Date Received
    February 28, 2011
    Date of Event
    March 4, 2009
    Report Date
    March 5, 2009
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTION OF THE BLADE INDICATED THAT THERE WERE NO DISCERNABLE SIGNS OF SCORING IN THE PLATING OR IN THE BLADE SUBSTRATE. DURING FIT AND ASSEMBLE OF THE BLADE THE INNER BLADE IS ROTATED WITHIN THE OUTER BLADE TO ENSURE THAT THE INNER BLADE SPINS FREELY AND THERE IS NO CONTACT BETWEEN THE BLADE EDGEFORMS. THE FIT OF THE BLADE INDICATES THAT THERE IS NO EXCESSIVE RUNOUT RESPONSIBLE FOR THE SHEDDING. SHEDDING OF THE PLATING MAY BE EXPERIENCED IN THE EVENT THAT THERE IS SIDE LOADING OF THE BLADE DURING USE. CONFIRMATORY SHED TESTING CANNOT BE COMPLETED AS VALID DATA CANNOT BE GENERATED IF A BLADE HAS PREVIOUSLY BEEN USED. NO ADDITIONAL INVESTIGATION IS WARRANTED AT THIS TIME. (B)(4)

    Description of Event or Problem · 1

    AT THE END OF THE CASE IT LOOKED LIKE SMALL SHEDDING (REALLY FINE GLITTER) IN THE PATIENTS UTERUS. THE BLADE WAS STERILE AND STAINLESS STEEL SO IT WILL PROBABLY BE EXPELLED IN HER NEXT MONTHLY CYCLE. THE DOCTOR BELIEVES THERE WILL NOT BE ANY COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECOLOGY DISPOSABL HYSTEROSCOPIC, ROTARY, MORCELLATOR HIH SMITH & NEPHEW ENDOSCOPY 7209509

    Patients

    Seq Age Sex Outcome Treatment
    1