BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIUM SURGICLIP

    MDR report key: 19851919 · Received July 29, 2024

    Report

    Report Number
    2647580-2024-03297
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 18, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    FZP
    PMA / PMN Number
    K143644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 134051, 134051 PREMIUM SURGICLIP II 9.75, (LOT #P3D0280); 134051, 134051 PREMIUM SURGICLIP II 9.75, (LOT #P3D0280) 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: G3, H3, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE INSTRUMENT WAS PARTIALLY APPLIED WITH EIGHT REMAINING CLIPS. THERE WAS NO CLIP LOADED IN THE JAW. THE DISTAL END OF THE CHANNEL COVER WAS INTACT. MICROSCOPIC INSPECTION OF THE JAWS REVEALED ACCEPTABLE JAW CO-PLANARITY. FOUR SCISSORED CLIPS WERE RECEIVED. FUNCTIONAL TESTING FOUND THAT THE INSTRUMENT WAS FIRST TEST FIRED ONCE IN AIR SO THAT THE CLIP FORMATION COULD BE OBSERVED. THE REMAINING CLIPS WERE FIRED ON TEST MEDIA WITH PROPER FORMATION. THE JAW AND HANDLE MOVED SMOOTHLY THROUGH THE FIRING CYCLE AND RETURNED TO THE OPEN POSITION. EACH REMAINING CLIP LOADED PROPERLY IN THE JAW. WHEN THE CARTRIDGE WAS EMPTY, THE INTERLOCK ENGAGED AND PREVENTED THE JAWS FROM APPROXIMATING. IT WAS REPORTED THAT THE CLIPS NOT LOADING PROPERLY. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. IT WAS ALSO REPORTED THAT THE COMPONENT DISENGAGED. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE CAN OCCUR IF THE DISTAL END OF THE DEVICE IS SUBJECTED TO EXCESSIVE MANIPULATION DURING APPLICATION OF THE INSTRUMENT. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: DO NOT EXCESSIVELY TWIST OR TORQUE THE JAWS. EXCESSIVE TWISTING OR TORQUING THE JAWS MAY DISLODGE CLIP FROM THE JAWS OR CAUSE CLIP M ALFORMATION AFTER JAW CLOSURE. 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 FLAP PROCEDURE, THE THREE CLIP APPLIERS EXPERIENCED ISSUES WITH THE LOADING OR FIRING OF THE CLIPS. THE CLIPS FELL INTO THE PATIENT'S CAVITY AND WERE RETRIEVED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375038 PREMIUM SURGICLIP CLIP, IMPLANTABLE FZP US SURGICAL PUERTO RICO 134048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SEE H11