BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFSILK

    MDR report key: 6725657 · Received July 19, 2017

    Report

    Report Number
    9612501-2017-05801
    Event Type
    Malfunction
    Date Received
    July 19, 2017
    Date of Event
    April 27, 2017
    Report Date
    August 24, 2017
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    OCW
    PMA / PMN Number
    K934738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. NEEDLE HAD MARKS ON THE CONES. NEEDLE WAS LAYERED IN BIOLOGICAL MATTER. NEEDLE WAS BENT. 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 MARKS ON THE CONE OF THE NEEDLE MAY OCCUR WHEN PRESSURE IS APPLIED ON THE TOGGLE LEVER OF THE SUTURING DEVICE PRIOR TO CLOSING THE HANDLES AND PREMATURELY ATTEMPTING TO TOGGLE. REPLICATION OF THE REPORTED CONDITION MAY OCCUR WHEN BIOLOGICAL RESIDUE BUILDS UP IN THE JAWS OF THE DEVICE FROM PROLONG USE OR USE IN MORE THAN ONE PROCEDURE. 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. HOWEVER, THE INVESTIGATION DETECTED A SECONDARY CONDITION OF PREMATURE TOGGLING THAT HAS A RELATIONSHIP TO THE REPORTED INCIDENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE. CORRECTION: PRODUCT CODE: OCW COMMON DEVICE NAME: ENDOSCOPIC TISSUE APPROXIMATION DEVICE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 · 1

    ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WOULD NOT HOLD THE SUTURE. TO COMPLETE THE PROCEDURE, ANOTHER DEVICE WAS USED. NO HARM WAS CAUSED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505692 SOFSILK ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW DAVIS & GECK CARIBE LTD 170004

    Patients

    Seq Age Sex Outcome Treatment
    1