BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGULAR POLYPECTOMY SNARE

    MDR report key: 3728639 · Received April 7, 2014

    Report

    Report Number
    3007305485-2014-00034
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 3, 2014
    Report Date
    April 29, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K820430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONMED SINGULAR POLYPECTOMY SNARE IS A SINGLE PATIENT USE, ONE PIECE, DISPOSABLE DEVICE THAT MAY BE UTILIZED IN CONJUNCTION WITH AN ELECTROSURGICAL GENERATOR FOR ENDOSCOPIC RESECTION OF A POLYPOID LESION. THE DHR/LHR, DEVICE HISTORY RECORD/LOT HISTORY RECORD, REVIEW REGARDING LOTS 1206014 AND 1212144 SHOWS THAT THESE DEVICES WERE PRODUCED ACCORDING TO CURRENT AND APPROVED PROCEDURES AND TESTING SPECIFICATIONS. NONCONFORMANCES REGARDING THE PRODUCT'S IDENTITY, QUALITY, SAFETY, EFFECTIVENESS, AND PERFORMANCE WERE NOT DOCUMENTED WITHIN THE DHR/LHR. BOTH DEVICES ASSOCIATED WITH THESE COMPLAINTS ARE NOT BEING RETURNED TO CONMED CORPORATION FOR EVALUATION. THE CUSTOMER COMPLAINT IS CONFIRMED BASED ON THE EVENT DESCRIPTION RECEIVED FROM THE END-USER. WITHOUT EVALUATING THE SUSPECTED DEVICES A CONCLUSIVE DETERMINATION OF ROOT CAUSE CANNOT BE MADE. WITH DEVICES NOT BEING RETURNED, OR PHOTOGRAPHS OF THE DEVICES, THERE WILL BE NO VERIFICATION OF THE REPORTED FAILURE MODE AND/OR VERIFICATION OF THE SUSPECT DEVICES AS CONMED PRODUCTS. THEREFORE, THESE COMPLAINTS ARE INCONCLUSIVE. A TWO YEAR REVIEW OF COMPLAINT HISTORY SHOWS THIS COMPLAINT AND THE COMPLAINT REPORTED ON MEDWATCH 1320894-2014-00035 (SAME FAILURE MODE, SAME FACILITY, SAME END-USER OPERATOR) AS ISOLATED INCIDENTS OF THIS REPORTED FAILURE MODE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE COMPLAINT IS INCONCLUSIVE. THE COMPLAINT INVESTIGATION HAS NOT IDENTIFIED A MANUFACTURING OR COMPONENT DEFECT; THEREFORE, CORRECTIVE ACTION IS NOT WARRANTED AT THE PRESENT TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. THIS IS ASSOCIATED WITH MEDWATCH 1320894-2014-00035. NEVER RETURNED TO CONMED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO CONMED FOR EVALUATION TO DATE. ON COMPLETION OF THE QUALITY ENGINEERING EVALUATION A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS MEDWATCH IS ASSOCIATED WITH MEDWATCH 3007305485-2014-00035 FILED FOR THE SECOND SURGERY. NOT YET RETURNED TO CONMED CORPORATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, " DURING THE POLYPECTOMY, THE SNARE GOT STUCK AROUND THE POLYP AND COULDN'T BE REMOVED. THIS HAPPENED ON 2 OCCASIONS. PROCEDURES PERFORMED BY (B)(6). BOTH PATIENTS REQUIRED LAPAROTOMY, BOTH DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208428 SINGULAR POLYPECTOMY SNARE SNARE FDI CONMED CORPORATION 1206014

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention