BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDOFLIP CATHETER

    MDR report key: 17595839 · Received August 22, 2023

    Report

    Report Number
    9681384-2023-00036
    Event Type
    Injury
    Date Received
    August 22, 2023
    Date of Event
    January 15, 2023
    Report Date
    August 22, 2023
    Manufacturer
    COVIDIEN AG JUAREZ (MMJ)
    Product Code
    FFX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE EVENTS: LAWRENCE JUN LEUNG GENE K. MA JEFFREY K. LEE NORIO FUKAMI YEAR: 2023 SUCCESSFUL DESIGN AND IMPLEMENTATION OF A POEM PROGRAM FOR ACHALASIA IN AN INTEGRATED HEALTHCARE SYSTEM DIGESTIVE DISEASES AND SCIENCES (2023) 68:2276¿2284 HTTPS://DOI.ORG/10.1007/S10620-023-07839-Y RECEIVED: 13 SEPTEMBER 2022 / ACCEPTED: 15 JANUARY 2023 / PUBLISHED ONLINE: 1 FEBRUARY 2023 © THE AUTHOR(S), UNDER EXCLUSIVE LICENCE TO SPRINGER SCIENCE+BUSINESS MEDIA, LLC, PART OF SPRINGER NATURE 2023 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 STUDY, A RETROSPECTIVE EVALUATION AIMED TO DESCRIBE THE CLINICAL OUTCOMES OF A DEVELOPING COMPREHENSIVE PER ORAL ENDOSCOPIC MYOTOMY (POEM) SERVICE BETWEEN JANUARY 2019 AND DECEMBER 2020. THE PROBE WAS USED IN 41 PATIENTS WITH ACHALASIAUNDERGOING THE POEM PROCEDURE, TO MEASURE THE LOWER ESOPHAGEAL SPHINCTER DISTENSIBILITY INDEX. ONE ADVERSE EVENT OCCURRED, WHEN THE PROBE TIP ADVANCED INTO THE SUBMUCOSAL TUNNEL, CAUSING A MUCOSOTOMY, REQUIRING CLIPS FOR CLOSURE. AN ESOPHAGOGASTRODUODENOSCOPY WASPERFORMED AND CONFIRMED THE FORMATION OF A SUBMUCOSAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306868 UNKNOWN ENDOFLIP CATHETER SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX COVIDIEN AG JUAREZ (MMJ) UNKNOWN ENDOFLIP CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention