BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP II

    MDR report key: 16854237 · Received May 2, 2023

    Report

    Report Number
    2647580-2023-01839
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 2, 2023
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    FZP
    UDI-DI
    10884521057562
    PMA / PMN Number
    K143644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 134051 - 134051 PREMIUM SURGICLIP II 9.75, LOT# P2L0132 134051 - 134051 PREMIUM SURGICLIP II 9.75, LOT# P2L0132. 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 AN OPEN LIVER RESECTION, WHEN LIGATING THE VESSELS OF LIVER WHILE DISSECTING, THERE WERE ISSUES EXPERIENCED WITH LOADING OR FIRING OF THE CLIPS FOR THE THREE DEVICES. THE CLIPS WERE UNABLE TO BE EXERTED IN RIGHT POSITION WITHIN THE JAW. THE CLIPS ARE SUPPOSED TO BE ALIGN WITH THE TIP OF THE JAW, HOWEVER THE MORE THE CLIPS ARE LOADED, THE LOWER END OF THE JAW THEY ARE POSITIONED. A COMPETITOR'S PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161489 PREMIUM SURGICLIP II CLIP, IMPLANTABLE FZP US SURGICAL PUERTO RICO 134051 P2L0132 10884521057562

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown