BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO CLIP III

    MDR report key: 10543852 · Received September 16, 2020

    Report

    Report Number
    9612501-2020-01323
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 27, 2020
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    UDI-DI
    10884521057852
    PMA / PMN Number
    K100242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4(EXPIRATION DATE, LOT#), D10, G4, H3, H4, H6 H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE WISHBONE LINK WAS DISCONNECTED FROM THE TRIGGER HANDLE AND THE TRIGGER WAS FLACCID. THE INSTRUMENT WAS UNABLE TO BE CYCLED AS THE HANDLE WAS NOT CONNECTED TO THE INTERNAL LINKAGE. THE INSTRUMENT ALSO WAS DISMANTLED FOR VISUALIZATION OF TRIGGER AND INTERNAL COMPONENTS. IT WAS OBSERVED THAT THE WISHBONE LINK HAD DISCONNECTED FROM THE TRIGGER HANDLE. THE WISHBONE LINK WAS REATTACHED. THE INSTRUMENT WAS REASSEMBLED, AND EIGHT CLIPS WERE APPLIED TO TEST MEDIA WITH PROPER CLIP FORMATION. WHEN THE CARTRIDGE WAS EMPTY, THE INTERLOCK ENGAGED TO PREVENT THE JAWS FROM APPROXIMATING. IT WAS REPORTED THAT THE JAWS OF THE DEVICE DID NOT OPEN COMPLETELY. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. IT WAS ALSO REPORTED THAT THE CLIPS DID NOT LOAD PROPERLY INTO THE JAWS AS EXPECTED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. 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: SQUEEZE THE HANDLE FIRMLY AS FAR AS IT WILL GO. FAILURE TO SQUEEZE THE HANDLE COMPLETELY MAY RESULT IN AN IMPROPERLY FORMED CLIP AND POSSIBLE BLEEDING AND/OR LEAKAGE. FAILURE TO SQUEEZE COMPLETELY MAY PREVENT THE JAWS FROM OPENING. REPLICATION OF THE DISENGAGED WISHBONE LINK CONDITION MAY OCCUR IF THE HANDLE IS FORCEFULLY PULLED OPEN PRIOR TO FULLY COMPLETING THE FULL HANDLE COMPRESSION. 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, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE CLIP APPLIER WAS BEING LOADED, THE HANDLE WAS ABLE TO BE SQUEEZED, BUT THE JAWS ARE TOO NARROW TO GET TO THE TISSUE. IT WAS ALSO REPORTED THAT AFTER FIRING THE DEVICE THE JAWS OPENED WIDER INSTEAD OF CLIPPING THE TISSUE. THE CLIPS WERE NOT LOADED PROPERLY. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006117 ENDO CLIP III CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD 176630 J0A1369Y 10884521057852

    Patients

    Seq Age Sex Outcome Treatment
    1