BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 2236090 · Received September 7, 2011

    Report

    Report Number
    1320894-2011-00069
    Event Type
    Injury
    Date Received
    September 7, 2011
    Date of Event
    October 11, 2010
    Report Date
    September 14, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONMED CORPORATION MANUFACTURES NUMEROUS ENDOSCOPIC GUIDEWIRES {FXWIRE ADVANCED MEASUREMENT GUIDEWIRE, DIRECTOR GUIDEWIRE SYSTEM, XWIRE GUIDEWIRE, MARKED SPRING TIP GUIDEWIRE, AND A GUIDEWIRE IN OUR PEG (PERCUTANEOUS ENTERAL GASTROSTOMY) KITS}. WITH THIS REPORTED INCIDENT CONMED IS UNSURE OF WHICH GUIDEWIRE PRODUCT MAY HAVE BEEN UTILIZED BY THE PHYSICIAN NAMED IN THIS SUBPOENA, OR, IF A CONMED GUIDEWIRE PRODUCT WAS EVEN UTILIZED DURING THE MENTIONED PROCEDURE. THE FDA PRODUCT CODE SHOULD HAVE BEEN LEFT BLANK FOR THE GUIDEWIRES MANUFACTURED BY CONMED ARE CLASSIFIED UNDER MORE THAN ONE PRODUCT CODE AND THE ACTUAL PRODUCT THAT WAS INVOLVED IN THIS INCIDENT IS UNKNOWN. THIS EMDR SOFTWARE WOULD NOT LET ME COMPLETE THIS SUBMISSION WITHOUT A REPORTED FDA PRODUCT CODE; THEREFORE, FDA PRODUCT CODE KOG, ENDOSCOPE AND/OR ACCESSORIES, A CLASS II DEVICE UNDER CLASSIFICATION PANEL - GASTROENTEROLOGY-UROLOGY AND CFR SECTION 876.1500 - ENDOSCOPE AND ACCESSORIES WAS USED, FOR THE MAJORITY OF CONMED'S ENDOSCOPIC GUIDEWIRES ARE CLASSIFIED UNDER THIS FDA PRODUCT CODE. HOWEVER, AN ENDOSCOPIC GUIDEWIRE MANUFACTURED BY CONMED IS ALSO CLASSIFIED UNDER FDA PRODUCT CODE KNQ, DILATOR, ESOPHAGEAL, A CLASS II DEVICE UNDER CLASSIFICATION PANEL - GASTROENTEROLOGY-UROLOGY AND CFR SECTION 876.5365 - ESOPHAGEAL DILATOR. IF THE INVESTIGATION VERIFIES THE PRODUCT CATALOG NUMBER OF THE DEVICE INVOLVED IN THIS INCIDENT AND THE WRONG FDA PRODUCT CODE HAS BEEN REPORTED, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE CORRECTED DATA. A SUPPLEMENTAL REPORT WILL BE FILED WHEN THE QUALITY ENGINEERING INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF HOW THIS REPORT WAS RECEIVED (LEGAL SUBPOENA - COMPLAINT WITH JURY DEMAND) ADDITIONAL INFORMATION IS NOT ATTAINABLE BY THIS DEPARTMENT. NO DHR REVIEW WAS POSSIBLE, AS THE LOT NUMBER FOR THIS PRODUCT HAS NOT BEEN MADE AVAILABLE. THE FDA PRODUCT CODE REMAINS UNKNOWN. IT COULD BE EITHER FDA PRODUCT CODE KOG, ENDOSCOPE AND/OR ACCESSORIES, A CLASS II DEVICE UNDER CLASSIFICATION PANEL - GASTROENTEROLOGY-UROLOGY AND CFR (B)(4). ENDOSCOPE AND ACCESSORIES, OR, FDA PRODUCT CODE KNQ, DILATOR, ESOPHAGEAL, A CLASS II DEVICE UNDER CLASSIFICATION PANEL - GASTROENTEROLOGY-UROLOGY AND (B)(4). ESOPHAGEAL DILATOR. CONMED MANUFACTURES ENDOSCOPIC GUIDEWIRES UNDER BOTH OF THESE FDA PRODUCT CODES AND CLASSIFICATIONS. NO PRODUCT WAS RETURNED FOR EXAMINATION OR CONFIRMATION OF DEFECT OR CONMED PRODUCT. FURTHERMORE, DUE TO THE UNKNOWN CATALOG NUMBER, IT IS NOT POSSIBLE TO TREND THE COMPLAINT FAILURE MODE WITHIN CUSTOMER COMPLAINT HISTORY. CONMED CORPORATION MANUFACTURES NUMEROUS ENDOSCOPIC GUIDEWIRES. NO RISK OR ROOT CAUSE IS DETERMINED DUE TO LACK OF CATALOG NUMBER & PRODUCT INFORMATION. THERE COULD BE MULTIPLE OF POSSIBLE CAUSES EITHER MANUFACTURING, HANDLING OR END USER RELATED ISSUE(S) FOR THIS FAILURE MODE. NO ROOT CAUSES CAN BE CONFIRMED WITHOUT EXAMINATION OF THE PRODUCT. NO PRODUCT DEFECTS WERE ABLE TO BE IDENTIFIED WITH THIS INVESTIGATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. THE COMPLAINT CAN BE NEITHER CONFIRMED NOR UNCONFIRMED AT THIS TIME. IF THE PRODUCT IS RETURNED IN THE FUTURE, THE COMPLAINT MAY BE RE-OPENED AND A FURTHER INVESTIGATION WILL BE PERFORMED. CONMED IS CONSIDERING THIS COMPLAINT CLOSED. DEVICE UNAVAILABLE - NOT RETURNED

    Description of Event or Problem · 1

    (B)(6): "ON OCTOBER 11, 2010, XXXXX WAS ADMITTED TO (B)(6) FOR AN UPPER ENDOSCOPY WITH SAVARY DILATION OF THE ESOPHAGUS TO BE PERFORMED BY YYYYY. DURING THE PROCEDURE, YYYYY USED A SURGICAL GUIDEWIRE DESIGNED, MANUFACTURED, AND SOLD BY CONMED, RESULTING IN AN ESOPHAGEAL PERFORATION. SUBSEQUENT SURGERIES WERE REQUIRED TO REPAIR THE PERFORATION AND ADDRESS ADDITIONAL COMPLICATIONS AND, AS A RESULT, XXXXX SUSTAINED SEVERE AND PERMANENT INJURIES AND DAMAGES." (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN (GUIDEWIRE) KOG CONMED CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S