BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 20071907 · Received August 26, 2024

    Report

    Report Number
    2647580-2024-03757
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    August 4, 2024
    Report Date
    November 9, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003215
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 ONE PIECE OF PAPER WITH EIGHT IMAGES OF TISSUE. NO STAPLE LINES COULD BE PROPERLY IDENTIFIED IN THE EIGHT IMAGES. REINFORCEMENT MATERIAL WAS NOT VISIBLE. THE LISTED RELOAD COULD NOT BE SEEN IN THE RETURNED IMAGE. IT WAS REPORTED THAT THE STAPLE LINE WAS BLEEDING, AND THE STAPLE LINE CONTENT LEAK. THE REPORTED ISSUES COULD NOT BE 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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: SIGTRSB60AXT, IGTRSB60AXT 60MM XTR THK REINFORCED REL, (LOT #N4D2039Y) SIGTRSB60AMT, SIGTRSB60AMT 60MM MED THK REINFORCED REL, (LOT #N4D2149Y) EGIA60AMT, EGIA60AMT EGIA 60 ARTIC MED THICK SULU, (LOT #P3K1227) EGIA60AMT, EGIA60AMT EGIA 60 ARTIC MED THICK SULU, (LOT #P3K1227). 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: B5, G3, H6 (IMF F0801 REMOVED) 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, FOLLOWING A PROCEDURE, THERE WAS AN EXCESSIVE STAPLE LINE BLEEDING AND LEAKAGE AT THE STOMACH. THE PATIENT VOMITED BLOOD AND THE PATIENT HAD AN ADDITIONAL SURGERY TO RESOLVE THE ISSUE. AN ENDOSCOPIC PROCEDURE WAS PERFORMED AT THE STOMACH AND THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AFTER. HOSPITALIZATION WAS EXTENDED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, ONE DAY POSTOPERATIVELY, THERE WAS EXCESSIVE STAPLE LINE BLEEDING AND LEAKAGE AT THE STOMACH. THE PATIENT VOMITED BLOOD, AND THE PATIENT HAD ADDITIONAL SURGERY TO RESOLVE THE ISSUE. AN ENDOSCOPIC PROCEDURE WAS PERFORMED AT THE STOMACH AND THE HOSPITALIZATION WAS EXTENDED FOR TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    882238 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EGIA60AMT P3K1227 10884523003215

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Female Hospitalization| R