BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH* 10MM SUTURING DEVICE

    MDR report key: 5994652 · Received October 3, 2016

    Report

    Report Number
    9612501-2016-00699
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 12, 2016
    Report Date
    September 12, 2016
    Manufacturer
    COVIDIEN
    Product Code
    KOG
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: POST MARKETING VIGILANCE (PMV) RECEIVED ONE DEVICE OPENED BY THE ACCOUNT WITH THE APPROPRIATE DISPLAY BOX AND BLISTER PACKAGING. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. A NEEDLE WAS FOUND IN THE JAWS OF THE INSTRUMENT. THE NEEDLE WAS NOT OBSERVED TO HAVE ANY WITNESS MARKS ON THE CONES. NO WITNESS MARKS ON THE BEVEL WALL WERE OBSERVED ON THE INSTRUMENT. NO SHEERING WAS OBSERVED ON THE TOGGLE SWITCHES. THE INSTRUMENT WAS LOADED WITH A PMV NEEDLE 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. THE INSTRUMENT WAS FOUND TO FUNCTION PROPERLY AND EACH NEEDLE REMAINED INTACT. NO DIFFICULTY WAS EXPERIENCED IN LOADING, UNLOADING, OR TOGGLING THE NEEDLE. THE FILE WAS CONCLUDED TO BE TESTED SATISFACTORILY AS THE DEVICE WAS FOUND TO MEET ALL VISUAL AND FUNCTIONAL TEST SPECIFICATIONS. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) FOR ADDITIONAL DEVICES USED IN THE SAME CASE. (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. A SUPPLEMENTAL WILL BE SUBMITTED UPON RECEIPT OF ANY NEW INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH) PROCEDURE, THE DEVICE HAD TROUBLE LOADING AND THEN DROPPED THE NEEDLE. IT FELL INTO THE CAVITY OF THE PATIENT BUT WAS RETRIEVED. THE SURGICAL TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES. THE LAST KNOWN STATUS OF THE PATIENT IS GOOD, NO PROBLEMS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT THE NEEDLE DROPPED INTO THE ABDOMEN OF THE PATIENT BUT IT WAS RECOVERED WITH GRASPERS. THE PROCEDURE WAS DELAYED BECAUSE OF THE DEVICE HAVING PROBLEMS LOADING AND THEN DROPPING THE NEEDLE. HAD TO GO AND GET ANOTHER HANDLE AND SUTURE RELOADS TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645570 ENDO STITCH* 10MM SUTURING DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG COVIDIEN 173016 J6F1794X

    Patients

    Seq Age Sex Outcome Treatment
    1