BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO STITCH

    MDR report key: 7327236 · Received March 9, 2018

    Report

    Report Number
    9612501-2018-00473
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 20, 2018
    Report Date
    April 11, 2018
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. DEVICE HAD BENT BLADES. A BROKEN NEEDLE WAS RETURNED LOADED IN LEFT JAW OF DEVICE. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. ANALYSIS CONCLUDED THERE WERE NO ASSEMBLY COMPONENT RELATED FAILURES. REPLICATION OF THE BENT BLADE INDICATES THAT THE INSTRUMENT MAY HAVE BEEN EXPOSED TO AN EXTERNAL FORCE WHICH BENT THE EXPOSED METAL BARS. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. 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.

    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: OCCURRED DURING A LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) PROCEDURE. THE SUTURING DEVICE WAS DIFFICULT TO LOAD AND UNLOAD. THERE WERE NO ISSUES USING THE DEVICE. FOUR NEEDLES ALSO BROKE. ONE HALF OF THE NEEDLE IS STILL LOADED IN THE DEVICE. ALL OF THE NEEDLE WERE RETRIEVED. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A NEW SUTURING DEVICE WAS OPENED. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS REPORTED AS NO INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) PROCEDURE. THE SUTURING DEVICE WAS DIFFICULT TO LOAD AND UNLOAD. THERE WERE NO ISSUES USING THE DEVICE. FOUR NEEDLES ALSO BROKE. ONE HALF OF THE NEEDLE IS STILL LOADED IN THE DEVICE. ALL OF THE NEEDLE WERE RETRIEVED. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, A NEW SUTURING DEVICE WAS OPENED. THERE WAS NO PATIENT HARM. THE PATIENT OUTCOME IS REPORTED AS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169467 ENDO STITCH ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173016 J7M1717EX

    Patients

    Seq Age Sex Outcome Treatment
    1