BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 6122765 · Received November 22, 2016

    Report

    Report Number
    9612501-2016-00942
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    May 30, 2017
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) RECEIVED ONE DEVICE. THE VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED: WITNESS MARKS FROM THE NEEDLE TIP IMPACTING THE BEVELED WALL WERE OBSERVED. NO SHEARING OF THE TOGGLE SWITCHES WAS OBSERVED FOR THE DEVICES UNDER MICROSCOPIC INSPECTION. PMV PERFORMED FUNCTIONAL TESTING ON DEVICE. DEVICE WAS LOADED WITH A NEEDLE FROM THE PMV INVENTORY AND APPLIED TO TEST MEDIA. PRESSURE WAS EXERTED ON THE NEEDLE IN ALL DIRECTIONS FROM BOTH SIDES OF THE JAWS DURING THIS TEST IN AN EFFORT TO SIMULATE CLINICAL CONDITIONS. DEVICE WAS FOUND TO NOT FUNCTION PROPERLY AS NEEDLE DISENGAGED WHILE BEING TOGGLED IN MEDIA AND BEING TOGGLE OUTSIDE OF MEDIA. NO DIFFICULTY WAS EXPERIENCED IN LOADING AND UNLOADING THE NEEDLE IN THE TESTED DEVICE. DIFFICULTY WAS EXPERIENCED IN TOGGLING THE NEEDLE IN THE DEVICE. DEVICE WILL BE FORWARDED TO ENGINEERING FOR FURTHER ANALYSIS AS DEVICE HAD JAWS THAT BECAME MISALIGNED AND NEEDLE WOULD DISENGAGE FROM DEVICE WHILE TOGGLING THROUGH TESTING MEDIA. 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).

    Additional Manufacturer Narrative · 1

    (B)(4)..

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A GASTRIC BYPASS SURGERY, THE NEEDLE RELEASED INSIDE THE COLON AND HAD TO BE RETRIEVED BY ADDING ENTEROTOMY. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THE NEEDLE FELL INTO THE PATIENT CAVITY AND WAS RETRIEVED WITHOUT PATIENT HARM. TO CORRECT THE CONDITION, A HAND SEWED ANASTOMOSIS WAS DONE. NO DEVICE FRAGMENT WAS LEFT IN THE PATIENT CAVITY. THE CURRENT PATIENT STATUS IS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772745 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6H1745X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention