BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITUATE

    MDR report key: 21867780 · Received April 18, 2025

    Report

    Report Number
    3005883396-2025-00001
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    April 3, 2025
    Report Date
    July 21, 2025
    Manufacturer
    COVIDIEN
    Product Code
    GDY
    UDI-DI
    10884521700604
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, H6 (FDR) 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

    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: D3 (MFR NAME, STREET 1, MFR CITY AND MFR REGION), G3, PMA/510(K) #, H3, H6. H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE SAMPLE WAS DAMAGED, AND THE RFID TAG FELL OUT. IT WAS REPORTED THAT A COMPONENT HAD DISENGAGED. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. 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. 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 SURGICAL PROCEDURE INVOLVING THE MITG RADIOFREQUENCY (RF) SURGICAL ACCESSORIES, A PIECE OR PART FELL INTO THE PATIENT'S CAVITY, WHICH WAS FULLY RETRIEVED AT THE END OF THE CASE WITHOUT THE NEED FOR AN X-RAY. THERE WAS NO ANOTHER PROCEDURE NEEDED TO REMOVE THE PIECE. ADDITIONALLY, A HOLE WAS DISCOVERED IN THE SPONGE WHEN IT WAS PULLED OUT OF THE SCROTAL SAC, PROMPTING THE SURGICAL TEAM TO SWITCH TO LAPS FOR THE REMAINDER OF THE CASE. THE GREEN SECTION OF THE SPONGE WAS FOUND WITH THE RFID TAG HANGING BY A THREAD, ABOUT TO DISLODGE. THE SURGICAL FIELD WAS SCANNED AND CLEARED AFTER THE FINAL COUNT. THERE WAS NO INJURY REPORTED AS A RESULT OF THE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE MITG RADIOFREQUENCY (RF) SURGICAL ACCESSORIES, A PIECE OR PART FELL INTO THE PATIENT'S CAVITY, WHICH WAS FULLY RETRIEVED WITHOUT THE NEED FOR AN X-RAY. ADDITIONALLY, A HOLE WAS DISCOVERED IN THE SPONGE WHEN IT WAS PULLED OUT OF THE SCROTAL SAC, PROMPTING THE SURGICAL TEAM TO SWITCH TO LAPS FOR THE REMAINDER OF THE CASE. THE GREEN SECTION OF THE SPONGE WAS FOUND WITH THE RFID TAG HANGING BY A THREAD, ABOUT TO DISLODGE. THE SURGICAL FIELD WAS SCANNED AND CLEARED AFTER THE FINAL COUNT. THERE WAS NO INJURY REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25052 SITUATE GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE GDY COVIDIEN G0404-16P01C-1 10884521700604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male