BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE

    MDR report key: 6582732 · Received May 22, 2017

    Report

    Report Number
    1643264-2017-21034
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    April 27, 2017
    Report Date
    June 6, 2018
    Manufacturer
    MITG-OKLAHOMA CITY
    Product Code
    HIH
    PMA / PMN Number
    K161763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE DEVICE SAMPLE WAS RECEIVED FOR EVALUATION. THIS DEVICE HAD BEEN USED IN THE TREATMENT OR DIAGNOSIS OF A PATIENT. A REVIEW OF THE LOT NUMBER REPORTED INDICATES THAT THE PRODUCT WAS WITHIN THE ASSIGNED EXPIRATION DATE AT THE TIME OF THE REPORTED INCIDENT. THE RETURNED PRODUCT DID NOT MEET SPECIFICATION AS RECEIVED. VISUAL INSPECTION FOUND THE BLADE WAS BROKEN. THE SLUFF CHAMBER HAS SCORE MARKS. THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION FOUND THE BLADE WAS BROKEN. THE BLADE SEIZED UP WHEN ACTIVATED IN THE FORWARD/REVERSE MODE. THE SLUFF CHAMBER OUTER DIMENSION WAS OUT OF SPECIFICATION. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE AN ASSEMBLY ERROR. CORRECTIVE ACTION HAS BEEN INITIATED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A PROCEDURE. THE BOTTOM OF THE BLADE BROKE OFF IN THE HAND CAUSING THE HAND PIECE TO BECOME VERY WARM. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363763 TRUCLEAR¿ ULTRA MINI TISSUE REMOVAL DEVICE HYSTEROSCOPE (AND ACCESSORIES) HIH MITG-OKLAHOMA CITY 72204064

    Patients

    Seq Age Sex Outcome Treatment
    1