BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 16312423 · Received February 7, 2023

    Report

    Report Number
    2647580-2023-00476
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    November 9, 2022
    Report Date
    February 7, 2023
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCT: UNKNOWN EEA - UNKNOWN EEA, LOT# UNKNOWN UNKNOWN EEA - UNKNOWN EEA, LOT# UNKNOWN TITLE: PRELIMINARY EVALUATION OF TWO-ROW VERSUS THREE-ROW CIRCULAR STAPLERS FOR COLORECTAL ANASTOMOSIS AFTER RECTAL RESECTION: A SIN GLE-CENTER RETROSPECTIVE ANALYSIS. SOURCE: INTERNATIONAL JOURNAL OF COLORECTAL DISEASE (2022) 37:2501¿2510 ACCEPTED: 9 NOVEMBER 2022 / PUBLISHED ONLINE: 17 NOVEMBER 2022. 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 LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2016 AND 2021 TO COMPARE OUTCOMES OF PATIENTS WHO UNDERWENT RECTAL RESECTION WITH TWO-ROW OR THREE-ROW STAPLERS, TRI-STAPLED CIRCULAR STAPLER WAS USED ON 178 PATIENTS FOR COLORECTAL END-TO-END ANASTOMOSIS. A HYDRO-PNEUMATIC TEST WAS PERFORMED TO CHECK THE INTEGRITY OF THE ANASTOMOSIS AND IF POSITIVE, AN ILEOSTOMY WAS PERFORMED. AN ILEOSTOMY WAS CREATED INTRAOPERATIVELY IN 22 PATIENTS. POSTOPERATIVE COMPLICATIONS INCLUDED: ANASTOMOTIC LEAK, ANASTOMOTIC HEMORRHAGE AND ANASTOMOTIC STENOSIS. PATIENTS WITH LEAK UNDERWENT DIAGNOSTIC COMPUTED TOMOGRAPHY SCAN AND REQUIRED REOPERATION, PERCUTANEOUS DRAINAGE OR ANTIBIOTICS. LENGTH OF STAY WAS PROLONGED. ANASTOMOTIC HEMORRHAGE REQUIRED ENDOSCOPIC TREATMENT AND ANASTOMOTIC STENOSIS REQUIRED ENDOSCOPIC DIAGNOSIS AND DILATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82339 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R