BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NO SCALPEL HEMOSTAT SHARP

    MDR report key: 15992101 · Received December 15, 2022

    Report

    Report Number
    3011137372-2022-00243
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    December 1, 2022
    Report Date
    December 5, 2022
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HRQ
    UDI-DI
    24026704515305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SAMPLE OF 244000 LOT T2 WAS RECEIVED FOR EVALUATION. NO VISUAL CONCERNS WERE NOTED WITH THE SAMPLE. A DIMENSIONAL OR FUNCTIONAL INSPECTION WAS NOT REQUIRED AS PART OF THIS INVESTIGATION. SAP WAS REVIEWED FOR NOTIFICATIONS PERTAINING TO INCOMING INSPECTION, STOCK CHECKS, AND PRODUCT RETURNS. NO CONCERNS WERE NOTED WITH REFERENCE TO 244000. THE DEVICE IS FABRICATED ACCORDING TO THE DESIGN SPECIFICATION. THE "NO SCALPEL" VASECTOMY FORCEPS FEATURES SHARP TIPS BY DESIGN. THE "NO SCALPEL" METHOD UTILIZES THE SHARP TIPS TO PUNCTURE THE SCROTAL TISSUE IN LIEU OF A SCALPEL AND MUST BE SHARP TO PERFORM THE PROCEDURE CORRECTLY.

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE TIP WAS TOO SHARP AND CUT AN EMPLOYEE WHEN TAKING IT OUT OF THE BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE TIP WAS TOO SHARP AND CUT AN EMPLOYEE WHEN TAKING IT OUT OF THE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2918959 NO SCALPEL HEMOSTAT SHARP HEMOSTAT HRQ TELEFLEX MEDICAL IPN004677 UNKNOWN 24026704515305

    Patients

    Seq Age Sex Outcome Treatment
    1 Female NONE REPORTED| NONE REPORTED