BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SCHROEDER TENACULUM-RCN-W42NU3240001

    MDR report key: 20938825 · Received December 12, 2024

    Report

    Report Number
    MW5163606
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    October 30, 2024
    Report Date
    October 28, 2024
    Manufacturer
    SKLAR CORPORATION DBA SKLAR INSTRUMENTS
    Product Code
    HFB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE DISPOSABLE TENACULUM (ORDER NUMBER 96-2624) INSTRUMENT BEING SUPPLIED TO BOTH (B)(6)AND THE 0B/GYN CLINIC, HAS BEEN REPORTED BY BOTH DEPARTMENTS AS CAUSING A SIGNIFICANT AMOUNT OF MORE BLEEDING THAN THE NON-DISPOSABLE INSTRUMENT. REQUESTING DISCONTINUATION OF THIS SPECIFIC TENACULUM AND ANOTHER DISPOSABLE OPTION. (B)(6) DISPOSABLE SURGICAL INSTRUMENTS. WHEN DOING INTRAUTERINE DEVICE INSERTIONS AND ENDOMETRIAL BIOPSIES, THE PROVIDERS HAVE VOICED DISSATISFACTION WITH THE TEN-INCH SCHROEDER TENACULUM, ITEM NUMBER 96-2624. THEY REPORT THAT THE ITEM CAUSES SIGNIFICANTLY MORE BLEEDING AND DISCOMFORT FOR THE PATIENT." AN ADDITIONAL MEMORANDUM SUBMITTED WITH THE SF 368 FROM (B)(6), LPN, FAMILY PRACTICE PROCEDURE CLINIC STATED. "SINCE 2020, THE FAMILY PRACTICE PROCEDURE ROOM HAS BEEN USING (B)(6) DISPOSABLE SURGICAL INSTRUMENTS. THE PROVIDERS THAT DO INTRAUTERINE DEVICE INSERTIONS HAVE VOICED DISSATISFACTION WITH THE TEN­ INCH SCHROEDER TENACULUM, ITEM NUMBER 96-2624. THEY REPORT THAT THE ITEM CAUSES SIGNIFICANTLY MORE BLEEDING AND DISCOMFORT FOR THE PATIENT." PER (B)(6), PSR'S WERE NOT SUBMITTED FOR THIS DEFECTIVE ITEM DUE TO BLEEDING OCCURRING DURING SURGICAL CASES ALREADY. INDIVIDUALS NOTIFIED ASIDE FROM CPT (B)(6) WERE (B)(6). (B)(6) EMAILED PRIME VENDOR, (B)(6), ON NOVEMBER 13, 2024, TO SUBMIT COMPLAINT ABOUT THE PRODUCT. VENDOR RESPONDED ON NOVEMBER 20, 2024, AND SAID THEY WOULD LOOK INTO THE PRODUCT. (B)(6) ATTEMPTED TO GET A CASE COMPLAINT NUMBER AND UPDATES FROM (B)(6) ON NOVEMBER 20 AND DECEMBER 5, 2024. THE LAST EMAIL STATED, "I FOLLOWED UP WITH THE MANUFACTURER BY PHONE TODAY BECAUSE I HAD NOT HEARD BACK BY EMAIL. I WAS TOLD THEY ARE STILL HANDLING THE CASE INTERNALLY AND WILL EMAIL ME AS SOON AS THEY HAVE A RESOLUTION." THE PRIME VENDOR, (B)(6), HAS NOT PROVIDED A CASE COMPLAINT NUMBER OR AN UPDATE SINCE DECEMBER 5, 2024. REFERENCE REPORT#: MW5163605.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 1/21/2025 FOR REPORT MW5163606 TO ADD ADDITIONAL DOCUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2393744 DISPOSABLE SCHROEDER TENACULUM-RCN-W42NU3240001 FORCEPS, BIOPSY, GYNECOLOGICAL HFB SKLAR CORPORATION DBA SKLAR INSTRUMENTS 600010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown