BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP II

    MDR report key: 20226022 · Received September 16, 2024

    Report

    Report Number
    2647580-2024-04009
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Date of Event
    August 23, 2024
    Report Date
    September 16, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    FZP
    UDI-DI
    10884521057562
    PMA / PMN Number
    K143644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 134051 - 134051 PREMIUM SURGICLIP II 9.75, LOT# P4E0830 134051 - 134051 PREMIUM SURGICLIP II 9.75, LOT# P4E0830 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING AN OPEN DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR (DIEP) PROCEDURE, THE CLIPS ON THE THREE CLIP APPLIERS DID NOT FULLY CLOSE AFTER BEING FIRED. A COMPETITOR'S DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471659 PREMIUM SURGICLIP II CLIP, IMPLANTABLE FZP US SURGICAL PUERTO RICO 134051 P4E0830 10884521057562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11