BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFSILK

    MDR report key: 12674674 · Received October 21, 2021

    Report

    Report Number
    9612501-2021-01742
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    September 30, 2021
    Report Date
    June 30, 2022
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAP
    UDI-DI
    10884521085220
    PMA / PMN Number
    K981128
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 TWO PARTIAL SUTURES AND A NEEDLE DETACHED. THE NEEDLE WAS RETURNED DISENGAGED FROM ANY SUTURE. UPON MICROSCOPIC INSPECTION OF THE NEEDLE, NORMAL CRIMP AND SWAGE MARKS WERE NOTED. IT WAS REPORTED THAT A COMPONENT DISENGAGED FROM THE DEVICE INTO THE SURGICAL CAVITY, AND THE NEEDLE UNEXPECTEDLY SEPARATED FROM THE THREAD. THE REPORTED ISSUES WERE CONFIRMED. THE MOST LIKELY CAUSE WAS DETERMINED TO BE MANUFACTURING RELATED. THESE ISSUES MAY OCCUR IF THE SUTURE IS NOT COMPLETELY INSERTED INSIDE THE NEEDLE¿S BARREL. INTERNAL PROCESS IMPROVEMENTS HAVE BEEN INITIATED TO MITIGATE THIS ISSUE. 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 LAPAROSCOPIC GASTRECTOMY, AS SUTURE WAS BEING PULLED OUT OF THE TROCAR NEEDLE POPPED OFF. ALSO, A THREAD BROKE AWAY FROM NEEDLE AT SWAGE WITHOUT ANY TENSION AND FELL OFF INTO THE PATIENT'S CAVITY. IT WAS THEN LOCATED AND RETRIEVED BY USING AN X-RAY DATED (B)(6) 2021. THE SURGICAL TIME WAS EXTENDED FOR 2 HOURS AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574049 SOFSILK SUTURE, NONABSORBABLE, SILK GAP DAVIS & GECK CARIBE LTD GS-832 D1E2527Y 10884521085220

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention