BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUCLEAR

    MDR report key: 22283800 · Received June 18, 2025

    Report

    Report Number
    1282497-2025-00419
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 18, 2025
    Manufacturer
    COVIDIEN MANSFIELD
    Product Code
    HIH
    UDI-DI
    10884521744110
    PMA / PMN Number
    K132015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: E3. 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

    D10 CONCOMITANT PRODUCT: 72203012, DENSE TIS SHAVER PLUS 72203012 TRUCLEAR (LOT#: 5831575). 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 DILATION AND CURETTAGE (D/C) HYSTEROSCOPY AND MYOMECTOMY PROCEDURE, PRIOR TO RESECTION, THE USE OF THE SHAVER RESULTED IN A LOSS OF VISUALIZATION, WHICH EXTENDED THE SURGICAL TIME BY 30 MINUTES. A NEW BLADE WAS OBTAINED BUT HAD THE SAME ISSUE. AN ADDITIONAL OPERATION WAS REQUIRED TO CORRECT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788551 TRUCLEAR HYSTEROSCOPE (AND ACCESSORIES) HIH COVIDIEN MANSFIELD 72203012 5831575 10884521744110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention PLEASE SEE NOTE ON H11.