BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIDAC

    MDR report key: 16040561 · Received December 22, 2022

    Report

    Report Number
    9612501-2022-02238
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 7, 2022
    Report Date
    January 20, 2023
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    UDI-DI
    20884521127019
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 173016 - 173016 ENDO STITCH INSTRUMENT, LOT #: J2G0204EY. 173016 - 173016 ENDO STITCH INSTRUMENT, LOT #: J2G0204EY. 173016 - 173016 ENDO STITCH INSTRUMENT, LOT #: J2G0204EY. 170044 -170044 ENDO STITCH TRI 2-0 GRN 120 S'DAC, LOT #: J2B2352Y. 170044 -170044 ENDO STITCH TRI 2-0 GRN 120 S'DAC, LOT #: J2B2352Y 170044 - 170044. ENDO STITCH TRI 2-0 GRN 120 S'DAC, LOT#: UNKNOWN. 170044 - 170044 ENDO STITCH TRI 2-0 GRN 120 S'DAC, LOT #: UNKNOWN. 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS AND HIATAL HERNIA REPAIR, DURING THE CREATION OF SIDE-TO-SIDE ANASTOMOSIS, THE DEVICES HAD UNLOADING DIFFICULTIES. THREE NEEDLES BROKE, DISENGAGED FROM THE HANDLE, AND FELL INTO THE PATIENT¿S CAVITY. ALL THREE NEEDLES WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER. A SINGLE-USE SUTURING DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS AND HIATAL HERNIA REPAIR, DURING THE CREATION OF SIDE-TO-SIDE ANASTOMOSIS, THE DEVICES HAD UNLOADING DIFFICULTIES. THE NEEDLES BROKE, DISENGAGED FROM THE HANDLE, AND FELL INTO THE PATIENTS CAVITY. THE NEEDLES WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER. A SINGLE-USE SUTURING DEVICE WAS USED INSTEAD. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109147 SURGIDAC ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 170044 J2B2352Y 20884521127019

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female SEE H10.