BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGI

    MDR report key: 18813071 · Received February 29, 2024

    Report

    Report Number
    3004904811-2024-00005
    Event Type
    Injury
    Date Received
    February 29, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 29, 2024
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    QSW
    UDI-DI
    10884521806870
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE CLIP ARMS SEPARATED FROM THE CLIP TUBE. IT WAS REPORTED THAT THE CLIP OF THE TRACTION WIRE SNAPPED UPON DEPLOYMENT. GRASPING FORCEPS WAS USED TO RETRIEVE BOTH THE WIRE AND THE BROKEN CLIP PIECE. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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 REPORTER, DURING THE PROCEDURE, THE CLIP OF THE TRACTION WIRE SNAPPED UPON DEPLOYMENT, SO IT COULDN'T BE USED. NOTHING ABNORMAL WAS NOTICED PRIOR TO DEPLOYMENT. GRASPING FORCEPS WAS USED TO RETRIEVE BOTH THE WIRE AND THE BROKEN CLIP PIECE DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2002451 PRODIGI ENDOSCOPIC TRACTION DEVICE QSW COVIDIEN LP BARRX ERD-TW35 B000002352 10884521806870

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention