BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPEL TUNNEL SYNDROME (CTS) RELIEF KIT

    MDR report key: 11169750 · Received January 14, 2021

    Report

    Report Number
    1017294-2021-00023
    Event Type
    Injury
    Date Received
    January 14, 2021
    Report Date
    March 24, 2021
    Manufacturer
    DESIGN STANDARDS CORP
    Product Code
    MDM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 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. A TWO-YEAR LOT HISTORY REVIEW SHOWS THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 2 COMPLAINTS, REGARDING 3 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4)DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. (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.

    Additional Manufacturer Narrative · 1

    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

    THE CUSTOMER, (B)(6), REPORTED AN ISSUE WITH THE INVOLVING A CTS RELIEF KIT, ITEM # 9971, LOT CN042916. INFORMATION RECEIVED INDICATES THAT THE CTS RELIEF KIT WAS BEING USED ON AN UNKNOWN DATE DURING A 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 CAMERA HOLDER. IT IS NOTED A SECOND KIT (SAME BATCH NUMBER) WAS THEN USED. IT IS NOTED THERE WAS NO INJURY TO THE PATIENT, HOWEVER THE SURGEON CHOOSE TO CONVERT TO AN OPEN PROCEDURE TO REMOVE THE PLASTIC FRAGMENTS. ADDITIONAL CLARIFICATION HAS BEEN REQUESTED BUT NONE RECEIVED TO DATE. 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
    68479 CARPEL TUNNEL SYNDROME (CTS) RELIEF KIT INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM DESIGN STANDARDS CORP CN042916

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OPTIC AND THE CAMERA HOLDER| OPTIC AND THE CAMERA HOLDER