BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCLEAR ULTRA RECIPROCATING MORC. 4.0

    MDR report key: 4685836 · Received April 13, 2015

    Report

    Report Number
    3003604053-2015-00002
    Event Type
    Malfunction
    Date Received
    April 13, 2015
    Date of Event
    December 22, 2014
    Report Date
    December 22, 2014
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    HIH
    PMA / PMN Number
    K041774
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. VISUAL INSPECTION OF THE RETURNED RECIPROCATING MORCELLATOR INDICATED THAT THERE WAS NO DAMAGE TO THE DEVICE ADAPTER BODY OR THE SLUFF CHAMBER. INSPECTION OF THE LASER MARKINGS ON THE INNER AND OUTER BLADE ASSEMBLIES INDICATED THAT THEY ARE IN THE CORRECT LOCATION. THE INNER BLADE ROTATED FREELY AND THE BLADE COULD BE PLACED INTO WINDOW LOCKED MANUALLY. THE FLUID FLOW DURING WINDOW LOCK WAS MEASURED UNDER SUCTION BY CONNECTING THE DEVICE TO A TRUCLEAR HANDPIECE AND CONTROLLER. THE SUCTION OUTFLOW WAS CONNECTED TO A VACUUM PUMP SET TO A PRESSURE OF 250 MMHG. THE RESULTING FLUID LOSS DID NOT CONFORM TO THE PERFORMANCE SPECIFICATION OF THE DEVICE. DIMENSIONAL INSPECTION OF THE SLUFF CHAMBER INDICATED THAT THE OUTER DIAMETER IS UNDERSIZED WHEN COMPARED TO THE COMPONENT SPECIFICATION. A CORRECTIVE ACTION WAS OPENED IN RESPONSE TO THIS ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO ATTACH THE INDEPENDENT MEDICAL ADVISOR¿S OPINION.

    Description of Event or Problem · 1

    DURING A HYSTEROSCOPIC POLYPECTOMY AND D&C UTILIZING THE TRUCLEAR ULTRA RECIPROCATING MORCELLATOR, IT WAS REPORTED THE SURGEON CHECKED THE PRE-WINDOW LOCKED BLADE BY STEPPING ON THE FORWARD FOOTSWITCH. IT WAS REPORTED TO HAVE BEEN LOCKED. DURING THE PROCEDURE WHEN THE BLADE WAS ACTIVATED THE BLADE AND HANDPIECE WAS SUCKING A LOT OF FLUIDS. THERE WAS A GREAT SEAL ON THE CERVIX SO NO LEAKING THERE. THE SURGEON REPORTED THAT SUCTION WAS DOWN TO 100 AND IT STILL WAS SUCKING A LOT OF FLUIDS. IT WAS REPORTED HE ENDED UP USING 4 BAGS OF 3L SALINE. FLUID DEFICIT WAS 720. THE SURGEON FINISHED THE CASE AND REMOVED ALL THE TISSUE. THERE WAS A BACKUP BLADE TO BE USED BUT DOCTOR WAS OK WITH THE CURRENT BLADE AND DIDN'T WANT TO OPEN ANOTHER BLADE. THERE WERE NO INJURIES TO THE PATIENT. PATIENT WENT TO RECOVERY AND WAS SENT HOME THE SAME DAY WITH NO HEALTH CONCERNS OR ISSUES FROM THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244549 TRUCLEAR ULTRA RECIPROCATING MORC. 4.0 HYSTEROSCOPE (AND ACCESSORIES) HIH SMITH & NEPHEW, INC. 72203012 B49150

    Patients

    Seq Age Sex Outcome Treatment
    1