BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SABRE 180

    MDR report key: 9734373 · Received February 20, 2020

    Report

    Report Number
    1720159-2020-00045
    Event Type
    Injury
    Date Received
    February 20, 2020
    Date of Event
    July 23, 2018
    Report Date
    February 19, 2020
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REGARDING CONCOMITANT MEDICAL PRODUCTS: CORD CONNECTOR MANUFACTURED BY NU-LIFE PRODUCT# JHY-CO-01-300, LOT# CO15071501. REUSABLE GROUNDING CABLE BY BOVIE PRODUCT# A1252C, LOT# 2018-08-27. MANUFACTURER NARRATIVE: TO DATE, THE REPORTED DEVICE WILL NOT BE RETURNED TO CONMED FOR EVALUATION. SHOULD THE DEVICE BE RETURNED, AN EVALUATION WILL BE PERFORMED; OR SHOULD RELEVANT INFORMATION BECOME AVAILABLE, WE WILL RE-OPEN AND MAY MODIFY OUR CONCLUSION. UPON COMPLETION OF THE COMPLAINT INVESTIGATION A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED. OTHERWISE, THIS FILING WILL STAND AS THE FINAL REPORT. THE SERVICE HISTORY COULD NOT BE REVIEWED SINCE A SERIAL NUMBER WAS NOT PROVIDED. A REVIEW OF THE DHR COULD NOT BE PERFORMED SINCE A SERIAL NUMBER WAS NOT PROVIDED. PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; VISUALLY INSPECT ALL ACCESSORIES BEFORE EACH USE TO VERIFY THE INTEGRITY OF THE INSULATION AND THE ABSENCE OF OBVIOUS DEFECTS. VERIFY THAT THE RETURN ELECTRODE CABLE IS CONNECTED TO THE RETURN ELECTRODE CONNECTOR. DO NOT USE CORDS AS HANDLES, DAMAGE TO THE INSULATION AND INCREASED RISK OF BURNS OR OTHER INJURIES MAY RESULT. USE ONLY ACCESSORIES THAT COMPLY WITH THE RELEVANT REGULATORY STANDARDS FOR YOUR LOCATION. HAZARDOUS CONDITIONS MAY RESULT FROM THE INAPPROPRIATE SELECTION, CONNECTION, OR USE OF ACCESSORIES. THE USE AND PROPER PLACEMENT OF A RETURN ELECTRODE IS A KEY ELEMENT IN THE SAFE AND EFFECTIVE USE OF ELECTROSURGERY IN MONOPOLAR PROCEDURES PARTICULARLY IN THE PREVENTION OF BURNS. THE OUTPUT POWER SELECTED SHOULD BE AS LOW AS POSSIBLE AND ACTIVATION TIMES SHOULD BE AS SHORT AS POSSIBLE FOR THE INTENDED PURPOSE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    CONMED WAS INFORMED OF A COMPLAINT FOR THE SABRE 180 ELECTROSURGICAL UNIT, THAT WAS USED IN A COLONOSCOPY ON (B)(6) 2018 IN WHICH THE" CAUTERY MACHINE MALFUNCTIONED WHILE THE SURGEON HAD THE SNARE (UNKNOWN MANUFACTURER) AROUND THE TISSUE, THE CAUTERY CABLE WAS COMPLETELY EXPLODED." PATIENT REPORTED COMPLICATIONS FROM THE COLONOSCOPY. THERE IS NO OTHER INFORMATION AVAILABLE. THIS REPORT IS BEING RAISED BASED ON ALLEGED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196287 SABRE 180 ESU GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CORD, CABLE