BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP II

    MDR report key: 23022164 · Received September 10, 2025

    Report

    Report Number
    2647580-2025-02786
    Event Type
    Malfunction
    Date Received
    September 10, 2025
    Date of Event
    September 9, 2025
    Report Date
    December 2, 2025
    Manufacturer
    COVIDIEN
    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

    ADDITIONAL INFORMATION: D4, G3, H3, H6 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 THAT THE THREE IMAGES OF CLIPS AND ONE IMAGE OF A 134051. THE INSTRUMENT WAS PARTIALLY VISIBLE. THE JAWS OF THE INSTRUMENT WERE NOT VISIBLE. A PORTION OF THE SHAFT WAS VISIBLE BUT COULD NOT BE PROPERLY EXAMINED. FIVE SCISSORED CLIPS AND THREE FULLY FORMED LOOSE CLIPS COULD BE SEEN. IT WAS REPORTED THAT THE FIRST FIVE CLIPS WERE DEPLOYED BUT FAILED TO CLOSE PROPERLY; THE CLIP LEGS WERE CROSSED OVER LIKE SCISSORS. THE REPORTED ISSUES WAS 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. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT DURING A LOCAL FLAP OPEN PROCEDURE ON THE POSTERIOR SHOULDER, THE FIRST FIVE CLIPS WERE DEPLOYED BUT FAILED TO CLOSE PROPERLY; THE CLIP LEGS WERE CROSSED OVER LIKE SCISSORS. ANOTHER CLIP APPLIER WAS USED TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373030 PREMIUM SURGICLIP II CLIP, IMPLANTABLE FZP COVIDIEN 134051 P5D1136 10884521057562

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown