BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCLEAR ULTRA RECIPROCATING MORC. 4.0

    MDR report key: 4685831 · Received April 13, 2015

    Report

    Report Number
    3003604053-2015-00007
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Date of Event
    October 8, 2013
    Report Date
    October 8, 2013
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HIH
    PMA / PMN Number
    K041774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED BY SMITH & NEPHEW, INC., (B)(4), AS PART OF A REMEDIAL ACTION FOLLOWING THE ISSUANCE OF THE 483 ISSUED MARCH 26, 2015 TO SMITH & NEPHEW, INC., FEI NO: (B)(4). THIS MDR IS BEING FILED IN AN ABUNDANCE OF CAUTION. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A. AS DESCRIBED IN OUR RESPONSE TO THE 483, SMITH & NEPHEW, INC., (B)(4) IS ENGAGING AN INDEPENDENT CLINICIAN TO EVALUATE WHETHER LOSS OF DISTENSION COULD BE CONSIDERED A SERIOUS INJURY PER 21 C.F.R § 803.3. BASED ON THE ANALYSIS PROVIDED BY THIS INDEPENDENT CLINICIAN, SMITH & NEPHEW, INC., (B)(4) WILL DETERMINE WHETHER SUCH EVENTS DO MEET THE REPORTING REQUIREMENTS OF 21 C.F.R. PART 803. IN ADDITION, IN RESPONSE TO THE 483, SMITH & NEPHEW, INC., (B)(4) IS IN THE PROCESS OF IMPROVING ITS MDR ASSESSMENT PROCESS AND REPORTING PROCEDURES TO HELP ENSURE REPORTS ARE APPROPRIATELY FILED WITH THE AGENCY. INCLUDED WITHIN THESE IMPROVEMENTS IS A RETROSPECTIVE REVIEW OF COMPLAINTS NOT PREVIOUSLY REPORTED TO THE AGENCY TO VERIFY REPORTING DECISIONS IN ACCORDANCE WITH THE IMPROVED PROCESS. ACCORDINGLY, SMITH & NEPHEW, INC., (B)(4) MAY BE RETROSPECTIVELY FILING ADDITIONAL EVENTS, IF REQUIRED, TO THE AGENCY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    DURING AN UNKNOWN SURGERY USING THE TRUCLEAR ULTRA RECIPROCATING MORCELLATOR, IT WAS REPORTED THAT THE BLADE ALLOWED TOO MUCH FLUID TO COME THROUGH WHILE WINDOW LOCKED AND THE VISUALIZATION WAS POOR. THE PROCEDURE WAS REPORTED TO BE EXTENDED 5 MINUTES TO REGAIN VISUALIZATION. THERE WAS NO IMPACT TO THE PATIENT DURING SURGERY. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244327 TRUCLEAR ULTRA RECIPROCATING MORC. 4.0 HYSTEROSCOPE (AND ACCESSORIES) HIH SMITH & NEPHEW, INC. 72203012 A87820

    Patients

    Seq Age Sex Outcome Treatment
    1