BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAR

    MDR report key: 8861660 · Received August 5, 2019

    Report

    Report Number
    3004904811-2019-00032
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    June 6, 2019
    Report Date
    September 3, 2019
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    UDI-DI
    10884521211599
    PMA / PMN Number
    K142364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE USED 1190A-115A GENERATOR SYSTEM AND TWO USED 64082-01 WERE RECEIVED FOR EVALUATION. THE CUSTOMER REPORTED AN E95-PRESSURE LEAK DETECTED ERROR. THE VISUAL INSPECTION FOUND THE RF OUTPUT CABLE ALDEN CONNECTOR LOCK RING MISSING. THIS WAS NOT COMPLAINT RELATED. NO OTHER NOTABLE CONDITIONS WERE NOTED. THE INVESTIGATION FOUND THE DEVICES TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. NO FAILURE MODE WAS IDENTIFIED. THE INVESTIGATION COULD NOT DETERMINE THE ROOT CAUSE OF THE EVENT. THE REPORTED CONDITION WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED LOT / SERIAL NUMBER WAS COMPLETED AND NO ENTRIES PERTINENT TO THE REPORTED EVENT WERE NOTED AND THIS LOT WAS RELEASED MEETING ALL SPECIFICATIONS AS MANUFACTURED. SERVICE RECORDS INDICATE APPROVED UPGRADES REWORK WERE PERFORMED ON THIS SERIAL NUMBER THAT IS NOT RELATED TO THIS REPORTED EVENT AND THAT INSPECTIONS AND TESTING WAS PERFORMED ON THIS SYSTEM THAT CONFIRMED SYSTEM MET ALL SPECIFICATIONS. ALL SYSTEMS ARE TESTED PER THE FINAL PRODUCT RELEASE TESTING MPI PRIOR TO RELEASE. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING ESOPHAGOGASTRODUODENOSCOPY, THE GENERATOR WAS ATTEMPTED WITH 2 DIFFERENT PROBES BUT COULD NOT HOLD INSUFFLATION. THEY USED AN ULTRA-LONG FOCAL CATHETER AND THEY WERE ABLE TO ACHIEVE 35 ABLATIONS AND THEN THE PROCEDURE WAS ABORTED. THE GENERATOR DISPLAYED AN ERROR CODE E95 - AIR LEAK. THERE WAS NO PATIENT AND USER HARM, AND NO MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS PREPPED FOR THE PROCEDURE AND WAS UNDER ANESTHESIA. A REPEAT PROCEDURE ON A DIFFERENT DATE WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655840 DAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN LP BARRX 64082 F2508041X 10884521211599

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR