BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO CLIP III

    MDR report key: 10199714 · Received June 26, 2020

    Report

    Report Number
    9612501-2020-00922
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    June 9, 2020
    Report Date
    September 4, 2020
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    UDI-DI
    10884521057852
    PMA / PMN Number
    K100242
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE AND A PHOTO WERE AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE WISHBONE LINK WAS DISCONNECTED FROM THE TRIGGER HANDLE AND THE TRIGGER WAS FLACCID. IT WAS REPORTED THAT THE JAWS OF THE DEVICE REMAINED CLOSED ON TISSUE AFTER FIRING. THE REPORTED ISSUE WAS CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THIS ISSUE CAN OCCUR IF THE HANDLE IS FORCEFULLY PULLED OPEN PRIOR TO FULLY COMPLETING THE FULL HANDLE COMPRESSION. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. 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. 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 · 0

    ADDITIONAL INFORMATION: G4, H3, H6, H3: EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE DEVICE HELD IN AIR. THE HANDLE WAS APPEARED TO BE ON RATCHET AND PARTIALLY CYCLED. THE PHOTO WAS TOO SMALL FOR A DESCRIPTION OF THE JAWS. IT WAS REPORTED THAT THE JAWS OF THE DEVICE REMAINED CLOSED ON TISSUE AFTER FIRING. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY ROOT CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE ALSO THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. 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

    (B)(4). 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 INGUINAL ROBOTIC RECURRENT LEFT INGUINAL HERNIA PROCEDURE, ONE CLIP WAS APPLIED ON THE VESSEL WITHOUT ISSUE. BUT WHEN APPLYING THE SECOND CLIP, THE HANDLE LOCKED UP AND WOULD NOT DISENGAGED. THE SURGEON CUT AROUND THE JAWS ONCE THE VESSELS WAS CLIPPED ON BOTH SIDES USING 4 ROBOTIC INTUITIVE STAPLES. THE SURGICAL PROCEDURE WAS EXTENDED FOR 45 MINUTES AND UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGED WAS CAUSED BY THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662864 ENDO CLIP III CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD 176630 J0A2423Y 10884521057852

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention