BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX

    MDR report key: 8952706 · Received August 30, 2019

    Report

    Report Number
    2027111-2019-00574
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 2, 2019
    Report Date
    October 22, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KWG
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING CONFIRMED THAT THERE WAS A TEAR IN THE SHEATH. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THE REPORTED EVENT WAS CAUSED BY THE INSTRUMENTATION THAT WAS USED DURING THE PROCEDURE. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS IN RESPONSE TO MEDWATCH# (B)(4). THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING CONFIRMED THAT THERE WAS A TEAR IN THE SHEATH. BASED ON THE CONDITION OF THE RETURNED UNIT, IT IS LIKELY THE REPORTED EVENT WAS CAUSED BY THE INSTRUMENTATION THAT WAS USED DURING THE PROCEDURE. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: ROBOTIC SIGMOIDECTOMY. DETAILED DESCRIPTION OF EVENT: REP WAS PRESENT FOR THE CASE. WHEN SURGEON WAS PULLING THE ALEXIS OUT AT THE END OF THE PROCEDURE NOTICED THERE WAS A TEAR IN THE SHEATH BY THE GREEN INSERTION RING. SHEATH DID NOT PARTICULATE. DEVICE IS AVAILABLE FOR RETURN. PATIENT STATUS: FINE. TYPE OF INTERVENTION: AT THE END OF THE CASE WHEN THE TEAR WAS NOTICED.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: ROBOTIC SIGMOIDECTOMY. DETAILED DESCRIPTION OF EVENT: REP WAS PRESENT FOR THE CASE. WHEN SURGEON WAS PULLING THE ALEXIS OUT AT THE END OF THE PROCEDURE NOTICED THERE WAS A TEAR IN THE SHEATH BY THE GREEN INSERTION RING. SHEATH DID NOT PARTICULATE. DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA MEDWATCH FORM UF #: (B)(4) ON 09OCT2019. PATIENT'S GENDER: FEMALE. DESCRIBE THE EVENT OR PROBLEM: ALEXUS LAPAROSCOPIC CAP (NO PATIENT HARM) FAILED ALEXUS PRODUCT. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: ROBOTIC ASSISTED LAPAROSCOPIC SIGMOID COLECTOMY. WHAT PROBLEM DID THE USER HAVE: DEVICE MALFUNCTION ¿ THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING). PATIENT STATUS: FINE. TYPE OF INTERVENTION: AT THE END OF THE CASE WHEN THE TEAR WAS NOTICED.

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    NAME OF PROCEDURE BEING PERFORMED: ROBOTIC SIGMOIDECTOM. DETAILED DESCRIPTION OF EVENT: REP WAS PRESENT FOR THE CASE. WHEN SURGEON WAS PULLING THE ALEXIS OUT AT THE END OF THE PROCEDURE NOTICED THERE WAS A TEAR IN THE SHEATH BY THE GREEN INSERTION RING. SHEATH DID NOT PARTICULATE. DEVICE IS AVAILABLE FOR RETURN. PATIENT STATUS: FINE. TYPE OF INTERVENTION: AT THE END OF THE CASE WHEN THE TEAR WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746256 C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX PROSTHESIS, FINGER, CONSTRAINED, METAL/POLYMER KWG APPLIED MEDICAL RESOURCES C8701 1350774

    Patients

    Seq Age Sex Outcome Treatment
    1 ROBOT