BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICUT® STRAIGHT SHAFT 4MM 11CM LONG

    MDR report key: 21442937 · Received February 24, 2025

    Report

    Report Number
    1045254-2025-00533
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    October 12, 2024
    Report Date
    February 24, 2025
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    UDI-DI
    00763000543846
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOUND THAT VISUALLY, THE POUCH WAS OPEN FROM 3 OF 4 SIDES WHEN RETURNED. THERE WAS NO DAMAGE NOTED TO THE TUBING SET, CLAMPS, CLIP NOR STYLETTE. HOWEVER, THE OUTER TUBE WAS SLIGHTLY BENT NEAR THE DISTAL END OF THE OUTER HUB. THE DISTAL END OF THE INNER HUB WAS DAMAGED AND HAD INDENTIONS. THE PROXIMAL END OF THE INNER SHAFT WAS ALSO DAMAGED WHEN RETURNED. FUNCTIONALLY, THE INNER ASSEMBLY SPUN BY HAND WITH SENSE OF BINDING. THE DEVICE WAS LOADED INTO A HANDPIECE, AND WHILE ROTATING IN OSCILLATING MODE UP TO 7,500 RPM, THE EXCESSIVE WOBBLING AND UNUSUAL NOISE WERE OBSERVED. FOR FURTHER ANALYSIS, THE INNER ASSEMBLY WAS PULLED OUT OF THE OUTER ASSEMBLY, AND IT WAS NOTICED THAT THE INNER SHAFT WAS BENT NEAR THE DISTAL END OF THE INNER HUB. THERE WERE ALSO STRIATIONS NOTED AT THE DISTAL END/TIP OF THE INNER SHAFT, AND ON THE SHAFT NEAR THE DISTAL END OF THE INNER HUB. ADDITIONALLY, THE INNER CUTTER TIP OUTSIDE DIAMETER SHALL MEASURE .1330+.000/-.0010 INCHES AND MEASURED .1329 INCHES. THE DEVICE FAILED DUE TO DEFECTIVE CONDITION UPON RETURN AND THE INABILITY TO SPIN PROPERLY. 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 ENDOSCOPIC NASAL POLYPECTOMY PROCEDURE, AFTER THE BLADE WAS CONNECTED TO THE HANDPIECE, STEPPED ON THE PEDAL AND IT WAS FOUND THAT THE ROTATIONAL SPEED WAS LOW AND ABNORMAL. AFTER INSPECTION, IT WAS FOUND THAT THERE WAS FRICTION BETWEEN THE INNER AND OUTER BLADES OF THE BLADE, WHICH WAS NOT FLEXIBLE AND CAUSED THE ROTATION SPEED TO BE VERY SLOW. AFTER REPLACING IT WITH A NEW BLADE, THE ROTATION SPEED WAS NORMAL AND THE OPERATION CONTINUED. THERE WAS NO ALLEGATION WITH THE FOUR PACKS. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403735 TRICUT® STRAIGHT SHAFT 4MM 11CM LONG BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1884004 0227106780 00763000543846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown