BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPS® BUR

    MDR report key: 19161991 · Received April 23, 2024

    Report

    Report Number
    9612501-2024-01027
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 18, 2024
    Report Date
    July 23, 2024
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    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

    H6: PREVIOUS FDC/ANNEX D CODE D14 NO LONGER APPLICABLE. 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

    ADDITIONAL INFORMATION RECEIVED STATING THAT THE BURRS WERE NOT TESTED WITH ANY OTHER SKEETER SINCE CUSTOMER DIDN'T HAVE ANY OTHER SKEETER TO TEST.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING HYSTERECTOMY PROCEDURE, THE PRODUCT HAD SHAKING WHEN FIRST USED, BUT AS IT WAS NOT A VERY SENSITIVE AREA, THE DOCTOR WAS ABLE TO USE IT. WHEN TRYING TO USE IT FOR THE SECOND TIME, EVEN AFTER CARRYING OUT SEVERAL TESTS, THE SHAKING PROBLEM PERSISTED. THERE WAS A PROCEDURE DELAY OF 60 MINUTES. THE PROCEDURE WAS PERFORMED WITH ANOTHER INSTRUMENT. PATIENT STATUS IS REPORTED AS ALIVE WITH NO INJURY. TESTS WERE CARRIED OUT ON THE DAY WITH THREE DIFFERENT BURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328453 XPS® BUR BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC DOMINICANA 3155648 0224695682

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown