BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIDAC

    MDR report key: 7327205 · Received March 9, 2018

    Report

    Report Number
    2647580-2018-01285
    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

    INVESTIGATION SUMMARY POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. BROKEN NEEDLE WAS RETURNED LODGED IN RIGHT JAW OF SUTURING DEVICE; NEEDLE WAS BROKEN AT LOADING SLOT. 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 OR BROKEN NEEDLE MAY OCCUR WHEN THE NEEDLE IS NOT LOADED PROPERLY OR WHEN THE NEEDLE IS FORCED INTO AN OBSTACLE. THIS CONDITION MAY ALSO OCCUR IF EXCESS PRESSURE IS EXERTED ON THE NEEDLE OR THE ATTACHED SUTURE WHILE THE JAWS ARE IN THE OPEN POSITION. IN THESE SITUATIONS, THE NEEDLE MAY FLEX AND ULTIMATELY BREAK. 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. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169459 SURGIDAC ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 173021 J7A012BX

    Patients

    Seq Age Sex Outcome Treatment
    1