BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CTS RELIEF KIT 4 EA

    MDR report key: 12388862 · Received August 30, 2021

    Report

    Report Number
    1017294-2021-00308
    Event Type
    Injury
    Date Received
    August 30, 2021
    Date of Event
    June 16, 2021
    Report Date
    September 9, 2021
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER COMPLAINT OF DETACHMENT OF BLUE PLASTIC FRAGMENTS INTO THE SURGICAL WOUND DURING THE PASSAGE OF THE OPTIC THROUGH THE CAMERA HOLDER WAS NOT CONFIRMED. A VISUAL EXAMINATION OF RETURNED USED DEVICES, ITEM 9971, QTY OF TWO (2) COULD NOT CONFIRM THE REPORTED PROBLEM, NO DAMAGE TO THE PRODUCT WAS OBSERVED. THE DEVICE WAS INSPECTED UNDER THE MICROSCOPE AND COULD NOT FIND ANY ISSUE OR BLUE FRAGMENTS CHIPPED OFF FROM CTS KIT, NO FAULT WAS FOUND. THE EXAMINATION WAS PERFORMED PER 9971 DESIGN PRINT. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD (DHR) OBTAINED FROM THE SUPPLIER DETERMINED THAT THERE IS NO EVIDENCE TO INDICATE THAT THERE WERE ANY DEVIATIONS IN THE MANUFACTURING PROCESS. ADDITIONALLY, THERE WERE NO ABNORMALITIES NOTED THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. (B)(4). THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. PER THE IFU, THE USER IS ALSO WARNED TO "CAREFULLY REVIEW THE SURGICAL TECHNIQUE BROCHURE AND VIDEO BEFORE PERFORMING THIS PROCEDURE." THE IFU ALSO GIVES SPECIFIC INSTRUCTIONS ON USING THE DEVICE, SURGICAL TECHNIQUE AND SIZES OF ACCESSORIES TO USE, INCLUDING SIZE OF OPTICS, SCOPE AND SHEATH. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    CONMED FRANCE RECEIVED NOTIFICATION OF ISSUES INVOLVING A CTS RELIEF KIT, ITEM # 9971, LOT CN042989. INFORMATION RECEIVED INDICATES THE HOSPITAL, CH DE BRIVE, REPORTED THAT DR. OSSAMA KHEDER WAS USING THE CTS RELIEF KIT ON (B)(6) 2021 DURING AN ENDOSCOPIC CARPEL TUNNEL SYNDROME TREATMENT. THE SURGEON REPORTED DETACHMENT OF BLUE PLASTIC FRAGMENTS IN THE SURGICAL WOUND DURING THE PASSAGE OF THE OPTIC THROUGH THE BLUE SHEATH. IT WAS NOTED THERE WAS NO INJURY TO THE PATIENT. IT ALSO NOTES ¿CLINICAL CONSEQUENCES: BLUE CHIPS IN THE OPERATIVE SITE. CONSERVATORY OR ACTIONS UNDERTAKEN: ABUNDANT WASHING. 2 MEDICAL DEVICES HAVE BEEN RETAINED.¿ CLARIFICATION RECEIVED INDICATED FRAGMENTS OF BLUE PLASTIC PEEL OFF (VISIBLY COMING FROM THE HOLES MACHINED IN THE OPTICAL GUIDE DURING THE INTRODUCTION OF THE OPTIC THROUGH THE BLUE CANNULA. THE FRAGMENTS CAME FROM THE INSIDE OF THE GUIDE AFTER 1-2 MINUTES OF USE. THE SIZE / TYPE OPTIC BEING USED WAS A 4 MM 30 DEGREE. THE OPTIC WAS NOT BEING USED WITH A SLEEVE AND IT WAS REPORTED THAT THE BIGGEST SIZE DILATOR WAS BEING USED. THE PROCEDURE WAS COMPLETED, HOWEVER IT INVOLVED A CONVERSION OF THE INCISION TO AN OPEN-PIT TECHNIQUE. ALL THE BLUE FRAGMENTS WERE REMOVED WITH THE DISSECTING FORCEPS AFTER THE CONVERSION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE TO FACILITATE REMOVING THE FRAGMENTS.

    Additional Manufacturer Narrative · 1

    NOTE: THIS REPORT IS BEING RESUBMITTED FOLLOWING AN UNSUCCESSFUL SUBMISSION ATTEMPT ON JULY 14, 2021 DUE TO A SYSTEM ERROR. AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    CONMED (B)(6) RECEIVED NOTIFICATION OF ISSUES INVOLVING A CTS RELIEF KIT, ITEM # 9971, LOT CN042989. INFORMATION RECEIVED INDICATES THE HOSPITAL, (B)(6), REPORTED THAT DR. (B)(6) WAS USING THE CTS RELIEF KIT ON (B)(6) 2021 DURING AN ENDOSCOPIC CARPEL TUNNEL SYNDROME TREATMENT. THE SURGEON REPORTED DETACHMENT OF BLUE PLASTIC FRAGMENTS IN THE SURGICAL WOUND DURING THE PASSAGE OF THE OPTIC THROUGH THE BLUE SHEATH. IT WAS NOTED THERE WAS NO INJURY TO THE PATIENT. IT ALSO NOTES ¿CLINICAL CONSEQUENCES: BLUE CHIPS IN THE OPERATIVE SITE. CONSERVATORY OR ACTIONS UNDERTAKEN: ABUNDANT WASHING. 2 MEDICAL DEVICES HAVE BEEN RETAINED.¿ CLARIFICATION RECEIVED INDICATED FRAGMENTS OF BLUE PLASTIC PEEL OFF (VISIBLY COMING FROM THE HOLES MACHINED IN THE OPTICAL GUIDE DURING THE INTRODUCTION OF THE OPTIC THROUGH THE BLUE CANNULA. THE FRAGMENTS CAME FROM THE INSIDE OF THE GUIDE AFTER 1-2 MINUTES OF USE. THE SIZE / TYPE OPTIC BEING USED WAS A 4 MM 30 DEGREE. THE OPTIC WAS NOT BEING USED WITH A SLEEVE AND IT WAS REPORTED THAT THE BIGGEST SIZE DILATOR WAS BEING USED. THE PROCEDURE WAS COMPLETED, HOWEVER IT INVOLVED A CONVERSION OF THE INCISION TO AN OPEN-PIT TECHNIQUE. ALL THE BLUE FRAGMENTS WERE REMOVED WITH THE DISSECTING FORCEPS AFTER THE CONVERSION. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE TO FACILITATE REMOVING THE FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279408 CTS RELIEF KIT 4 EA INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM DESIGN STANDARDS CORP CN042989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 4MM 30DEGREE OPTIC & BIGGEST SIZE DILATOR| 4MM 30DEGREE OPTIC & BIGGEST SIZE DILATOR