BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 8663305 · Received June 3, 2019

    Report

    Report Number
    1717344-2019-00708
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    April 9, 2019
    Report Date
    August 2, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    UDI-DI
    10884521612525
    PMA / PMN Number
    K162047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: ONE DEVICE WAS RECEIVED FOR EVALUATION. THE RETURNED PRODUCT DID NOT MEET SPECIFICATION AS RECEIVED. THE VISUAL INSPECTION FOUND THE KNIFE WAS TRAPPED INSIDE THE DEVICE JAW. THE KNIFE BLADE WAS PARTIALLY EXPOSED ON THE SIDE OF THE JAWS. THE JAWS WOULD NOT OPEN OR CLOSE DUE TO THE TRAPPED KNIFE. THERE WAS NO MISSING PIECE ON THE KNIFE BLADE. THE REPORTED CONDITION WAS CONFIRMED. KNIFE TRAP HAPPENS WHEN THE BLADE IS EXTENDED AND THE JAWS ARE NOT COMPLETELY CLOSED. THIS ALLOWS THE KNIFE TRACK TO OPEN TOO WIDE AND THE BLADE MOVES OUT OF ITS TRACK. AS A SAFETY MEASURE, THE KNIFE MUST BE RETRACTED IN ORDER TO OPEN THE JAWS. THE TISSUE IN THE WEBBING MAY HAVE PREVENTED THE KNIFE FROM RETRACTING FAR ENOUGH TO ALLOW THE JAWS TO OPEN. MORE FREQUENT CLEANING COULD HAVE ALSO REDUCED THE DIFFICULTY ACTIVATING THE KNIFE. THE INVESTIGATION IDENTIFIED THE ROOT CAUSE OF THE REPORTED EVENT TO BE KNIFE TRAP DUE TO USER ERROR. THE INSTRUCTIONS FOR USE (IFU) SATES, CONFIRM THAT THE JAWS HAVE REACHED THE CLOSED POSITION AND ARE LOCKED (THE HANDLE IS LATCHED) BEFORE ACTIVATING THE CUTTER. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE BLADE BROKE OFF WHILE IN USE. USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457424 LIGASURE IMPACT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER LF4418 90420203X 10884521612525

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR