BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUCLEAR

    MDR report key: 22476705 · Received July 11, 2025

    Report

    Report Number
    1282497-2025-00497
    Event Type
    Malfunction
    Date Received
    July 11, 2025
    Date of Event
    June 17, 2025
    Report Date
    December 22, 2025
    Manufacturer
    COVIDIEN MANSFIELD
    Product Code
    HIH
    UDI-DI
    10884521744080
    PMA / PMN Number
    K132015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 72202536, SOFT TIS SHAVER MINI 72202536 TRUCLEAR (LOT#:5822912), 72204064, TRUCLEAR ULTRA MINI TISSUE REMOVAL DEVIC (LOT#:UNKNOWN) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THERE WAS AN ADVERSE EVENT AND THE DEVICE WINDOW LOCK FAILED. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VAGINAL HYSTEROSCOPY (DILATION AND CURETTAGE) FOR POLYP RESECTION PROCEDURE, THE INTERNAL SHEATH OF THE SHAVER JUMPED OR ROTATED TOO FAST INSTEAD OF ROTATING SLOWLY WHEN THE WINDOW LOCK WAS ACTIVATED. THE SHAVER CONTINUED TO JUMP OR OSCILLATE INSTEAD OF WINDOW LOCKING APPROPRIATELY AFTER RESEATING THE SHAVER IN THE HANDPIECE AND UNPLUGGING AND REPLUGGING THE HANDPIECE TO THE CONTROL UNIT. A SECOND SOFT TISSUE MINI SHAVER FROM THE SAME LOT WAS OPENED AND EXHIBITED THE SAME WINDOW LOCK ISSUE. A DENSE BLADE WAS THEN OPENED, BUT THE SURGEON ULTIMATELY SWITCHED TO A CURETTE TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VAGINAL HYSTEROSCOPY (DILATION AND CURETTAGE) FOR POLYP RESECTION PROCEDURE, THE INTERNAL SHEATH OF THE SHAVER JUMPED OR ROTATED TOO FAST INSTEAD OF ROTATING SLOWLY WHEN THE WINDOW LOCK WAS ACTIVATED. THE SHAVER CONTINUED TO JUMP OR OSCILLATE INSTEAD OF WINDOW LOCKING APPROPRIATELY AFTER RESEATING THE SHAVER IN THE HANDPIECE AND UNPLUGGING AND RE-PLUGGING THE HANDPIECE TO THE CONTROL UNIT. A SECOND SOFT TISSUE MINI SHAVER FROM THE SAME LOT WAS OPENED AND EXHIBITED THE SAME WINDOW LOCK ISSUE. THE DISTENSION WAS LOST. A DENSE BLADE WAS THEN OPENED AND WORKED PROPERLY. HOWEVER, THE SURGEON ULTIMATELY SWITCHED TO A CURETTE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995104 TRUCLEAR HYSTEROSCOPE (AND ACCESSORIES) HIH COVIDIEN MANSFIELD 72202536 5822912 10884521744080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H11.