BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP

    MDR report key: 19668217 · Received July 3, 2024

    Report

    Report Number
    9612501-2024-01620
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    June 3, 2024
    Report Date
    September 2, 2024
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    UDI-DI
    10884521057845
    PMA / PMN Number
    K143644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE TUBE REVEALED THAT THE INSTRUMENT WAS PARTIALLY FIRED WITH FOURTEEN CLIPS REMAINING. THE HANDLE WAS NOT IN THE CORRECT POSITION. NO OTHER VISUAL ABNORMALITIES WERE OBSERVED. DURING FUNCTIONAL EVALUATION, IT WAS OBSERVED THAT THE JAWS WOULD NOT CLOSE UPON ACTUATION OF THE HANDLE. THE SHAFT WAS REMOVED FROM THE INSTRUMENT BODY AND THE BODY WAS DISASSEMBLED FOR VISUALIZATION OF INTERNAL COMPONENTS. THE SAFETY INTERLOCK CHANNEL LUGS WERE BROKEN. IT WAS REPORTED THAT THE CLIPS WERE NOT LOADING PROPERLY. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE ISSUE CAN OCCUR IF AN ATTEMPT WAS MADE TO FIRE THE INSTRUMENT WITHOUT FIRST LOADING A CLIP BY USING THE TRIGGER. THE SAFETY INTERLOCK FEATURE IS DESIGNED TO PREVENT THE JAWS FROM CLOSING ON A VESSEL IN THE ABSENCE OF A LOADED CLIP. IF AN ATTEMPT IS MADE TO FORCIBLY FIRE THE INSTRUMENT WHILE ENGA GED IN INTERLOCK, THE LUGS ARE DESIGNED TO BREAK AS NOTED AND THE INTERLOCK FEATURE CONTINUES TO FUNCTION AS INTENDED. 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: BEFORE ATTEMPTING TO SQUEEZE THE HANDLE, BE SURE TO FIRST LOAD A CLIP INTO THE INSTRUMENT JAWS. IF THE JAW IS EMPTY, THE INSTRUMENT WILL NOT CLOSE. ALWAYS CHECK TO SEE IF A CLIP IS SEATED IN THE JAWS PRIOR TO FIRING. WHEN SQUEEZING THE HANDLE, REMOVE THE FINGER FROM THE TRIGGER. DO NOT SIMULTANEOUSLY PULL THE TRIGGER AND SQUEEZE THE HANDLE AS THIS MAY RESULT IN THE FIRING OF AN UNFORMED CLIP OR JAMMING OF THE INSTRUMENT. 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

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SEGMENTECTOMY OF LIVER, AT THE TIME OF LIVER MOBILIZATION, THE SURGEON WAS ABLE TO SQUEEZE THE HANDLE BUT THERE WERE NO CLIPS ABLE TO LOAD PROPERLY INTO THE JAWS. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478324 ENDO CLIP CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD 176625 J2C0941NY 10884521057845

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown