BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILS¿ STITCH AUTO SUTURE¿ ARTICULATING SUTURING DEVICE 10MM

    MDR report key: 6153559 · Received December 7, 2016

    Report

    Report Number
    1219930-2016-01306
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Report Date
    November 9, 2016
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    OCW
    PMA / PMN Number
    K090419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4). ADDITIONAL INFORMATION: DEVICE RECEIVED FOR EVALUATION. DEVICE EVALUATION PENDING.

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. AN UNKNOWN SUBJECT NEEDLE WAS RECEIVED LOADED ONTO THE INSTRUMENT. NO VISUAL ABNORMALITIES WERE NOTED. A PMV NEEDLE WAS LOADED ONTO THE INSTRUMENT. THE NEEDLE DISENGAGED FROM THE JAWS UPON SEVERAL ATTEMPTS TO TOGGLE IT. IT WAS DETERMINED THAT THE BLADE WAS EXPOSED TO EXCESSIVE FORCE. PRODUCT ANALYSIS SUGGESTS THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. REPLICATION OF THE REPORTED CONDITION MAY BE DUE TO EXPOSING THE INSTRUMENT TO FORCES OUTSIDE OF PARAMETERS DUE ROUGH HANDLING OF THE DEVICE. THE PRODUCT ANALYSIS CONCLUDED THERE WERE NO DEVICE ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. THEREFORE, OUR INVESTIGATION WAS UNABLE TO ESTABLISH A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED INCIDENT. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER; THE DEVICE WOULD NOT LINE UP APPROPRIATELY AND THE SURGEON COULDN'T CONTINUE TO USE THE INSTRUMENT. NO FURTHER DETAILS REGARDING PATIENT, PRODUCT OR PROCEDURE WERE PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801207 SILS¿ STITCH AUTO SUTURE¿ ARTICULATING SUTURING DEVICE 10MM ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW COVIDIEN, FORMERLY US SURGICAL A DIVISON SILSSTITCH N6G0516X

    Patients

    Seq Age Sex Outcome Treatment
    1