BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EEA

    MDR report key: 20359041 · Received October 3, 2024

    Report

    Report Number
    2647580-2024-04275
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    September 18, 2024
    Report Date
    January 3, 2025
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GAG
    UDI-DI
    10884521593022
    PMA / PMN Number
    K172361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 020242, 020242 DISP PURSE STRING 65 X3, (LOT #P3E0091). 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: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED IT APPEARS THAT THE DONUT IS INCOMPLETE. IT WAS REPORTED THAT THE DONUT WAS INCOMPLETE. 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

    ACCORDING TO THE REPORTER, DURING A SUBTOTAL COLECTOMY, AFTER USING THE PURSE STRING SUTURE DEVICE FOR PROXIMAL SECTION OF THE COLON, THE CIRCULAR STAPLER WAS THE INSERTED AND FIRED. BEFORE REMOVING THE STAPLER, THE ANASTOMOSIS WAS INSPECTED AND A HOLE WAS FOUND IN THE PROXIMAL END. UPON CHECKING THE 'DONUTS', THE DISTAL DONUT WAS COMPLETE, THE PROXIMAL DONUT WITH THE PURSE STRING SUTURE WAS NOT COMPLETE WHERE THE HOLE HAD APPEARED. THE DOCTOR THEN SUTURED THE HOLE IN THE ANASTOMOSIS, THEN GAVE THE PATIENT A TEMPORARY STOMA TO ALLOW THE ANASTOMOSIS TIME TO HEAL. THE SURGICAL TIME WAS EXTENDED BY ONE HOUR DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878514 EEA STAPLER, SURGICAL GAG US SURGICAL PUERTO RICO TRIEEA28MT P3M0912 10884521593022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O SEE H11.