BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 21398187 · Received February 18, 2025

    Report

    Report Number
    2647580-2025-00538
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 11, 2025
    Report Date
    February 27, 2025
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523002966
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3 CORRECTION: B5, H6. 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 PRODUCT: EGIA45AVM EGIA 45 ARTIC VASC MED SULU (LOT#: UNKNOWN) 030451 ROTICULTR ENDO GIA 30-2.5 DLU (LOT#: T3F049X) EGIAUSTND ENDOGIA ULTRA UNIV STD STAP (LOT#: 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT SURGERY ON CALL FOR A LAPAROSCOPIC APPENDECTOMY. THREE STAPLE MAGAZINES WERE USED DURING THE OPERATION, AT THE MOMENT IT WAS NOT POSSIBLE TO REPORT WHICH MAGAZINE CRASHED INTO THE MANUAL HANDLE. ACCORDING TO THE OPERATING ROOM NURSE AND THE SURGEON, THEY FOUND NOTHING ABNORMAL AT THE STAPLE LINE OR ANY FOREIGN MATERIAL IN THE ABDOMEN. 9 DAYS AFTER THE LAPAROSCOPIC APPENDECTOMY SURGERY, REOPERATION WAS DONE WHERE THE STAPLE LINE HAS RUPTURED. THERE WAS STAPLE LINE LEAK. CORRECTION OF STAPLING LINE BY SUTURES WAS MADE, DRAINAGE OF ABSCESS AND SEARCH FOR FOREIGN BODY WAS DONE TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT FECALITIS WAS FOUND, WHICH INVOLVES THE DISTAL ILEUM AND THE CECAL POLE. NO FOREIGN MATERIAL CAN BE FOUND IN THE ABDOMEN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT SURGERY ON CALL FOR A LAPAROSCOPIC APPENDECTOMY. THREE STAPLE MAGAZINES WERE USED DURING THE OPERATION, AT THE MOMENT IT WAS NOT POSSIBLE TO REPORT WHICH MAGAZINE CRASHED INTO THE MANUAL HANDLE. ACCORDING TO THE OPERATING ROOM NURSE AND THE SURGEON, THEY FOUND NOTHING ABNORMAL AT THE STAPLE LINE OR ANY FOREIGN MATERIAL IN THE ABDOMEN. 9 DAYS AFTER THE LAPAROSCOPIC APPENDECTOMY SURGERY, REOPERATION WAS DONE WHERE THE STAPLE LINE HAS RUPTURED. CORRECTION OF STAPLING LINE BY SUTURES WAS MADE, DRAINAGE OF ABSCESS AND SEARCH FOR FOREIGN BODY WAS DONE TO RESOLVE THE ISSUE. IT WAS ALSO NOTED THAT FECALITIS WAS FOUND, WHICH INVOLVES THE DISTAL ILEUM AND THE CECAL POLE. NO FOREIGN MATERIAL CAN BE FOUND IN THE ABDOMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478112 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO 030419 P2D0092 10884523002966

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention