BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 21893095 · Received April 23, 2025

    Report

    Report Number
    1219930-2025-01919
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    March 27, 2025
    Report Date
    July 2, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003215
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT MEDICAL PRODUCTS: SIGPHANDLE, SIG POWER SIGPHANDLE HANDLE (SN:UNKNOWN); SIGPSHELL, SIG POWER SIGPSHELL CONTROL SHELL (LOT#UNKNOWN); SIGADAPTSTND, SIG POWER SIGADAPTSTND LINEAR ADAPTER (SN:UNKNOWN) 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

    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 OF THE RETURNED PHOTO NOTED ONE IMAGE OF A STAPLE LINE. BLOOD COULD BE SEEN ON THE TISSUE. STAPLES COULD NOT BE PROPERLY EXAMINED FOR PROPER FORMATION DUE TO IMAGE QUALITY. THE LISTED RELOAD WAS NOT VISIBLE IN THE RETURNED IMAGE. IT WAS REPORTED THAT THERE WAS STAPLE LINE BLEEDING. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. IT WAS ALSO REPORTED THAT THERE WAS ISSUE WITH STAPLE FORMATION. THE REPORTED ISSUE 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, POSTOPERATIVE TO THE HINOTORI LEFT HEMICOLECTOMY PROCEDURE, BLEEDING OCCURRED NEAR THE ANASTOMOTIC SITE, REQUIRING A BLOOD TRANSFUSION AND THE APPLICATION OF A CLIP VIA ENDOSCOPY. IT WAS UNCLEAR WHETHER THE STAPLER CAUSED THE BLEEDING, THOUGH A POTENTIAL ISSUE WITH STAPLE FORMATION WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124234 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT 10884523003215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L