BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 17952248 · Received October 17, 2023

    Report

    Report Number
    2647580-2023-04473
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    March 20, 2023
    Report Date
    October 17, 2023
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: SATISH K. WARRIER; 2023, IMPACT OF THE APPROACH ON CONVERSION TO OPEN SURGERY DURING MINIMALLY INVASIVE RESTORATIVE TOTAL MESORECTAL EXCISION FOR RECTAL CANCER.; INTERNATIONAL JOURNAL OF COLORECTAL DISEASE (2023) 38:83, HTTPS://DOI.ORG/10.1007/S00384-023-04382-0. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXPLORED THE IMPACT OF THE APPROACH ON CONVERSION IN PATIENTS UNDERGOING MINIMALLY INVASIVE RESTORATIVE TOTAL MESORECTAL EXCISION FOR RECTAL CANCER BETWEEN JANUARY 2006 AND JUNE 2020. THERE WERE 240 PATIENTS IN THE STUDY: 147 UNDERWENT A ROBOTIC APPROACH AND 93 UNDERWENT A LAPAROSCOPIC APPROACH AND A TRANS-ANAL APPROACH WAS UTILIZED IN 62 OF THE 240 PATIENTS. CIRCUMFERENTIAL RECTOTOMY AND THE ANASTOMOSIS WAS HAND-SEWN OR STAPLED USING THE COMPANY'S DEVICE. CONVERSION TO OPEN WAS REQUIRED IN ONE PATIENT WITH INADEQUATE PERFUSION. SEVERAL COMPLICATIONS WERE REPORTED SUCH AS ANASTOMOTIC LEAK, SUPERFICIAL SURGICAL SITE INFECTION, DEEP SURGICAL SITE INFECTION AND ILEUS. REOPERATIONS, PROLONGED HOSPITALIZATION AND READMISSIONS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95642 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H