BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRO-CLIP

    MDR report key: 22145547 · Received June 4, 2025

    Report

    Report Number
    1219930-2025-02410
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    April 21, 2025
    Report Date
    July 8, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GCJ
    PMA / PMN Number
    K925602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D1, D4, G,3, G4 (K925602). 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 A LAPAROSCOPIC LIVER RESECTION, A MALFUNCTION OCCURRED AND THE CLIP APPLIER FIRED AUTOMATICALLY, THE CLIP DID NOT HOLD TIGHTLY TO THE VESSEL AND DETACHED. AFTER THE DEVICE WAS REPLACED WITH A NEW APPLIER AND A NEW LIGATION CLIP, THE SURGERY WAS PERFORMED NORMALLY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852360 LAPRO-CLIP LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN LP LLC NORTH HAVEN 8886848798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown