BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIT KNIFE 2.8MM ANGL SNGL BEV W/SAFETY (10/SP)

    MDR report key: 24209613 · Received January 29, 2026

    Report

    Report Number
    1211998-2026-00003
    Event Type
    Injury
    Date Received
    January 29, 2026
    Date of Event
    December 29, 2025
    Report Date
    March 24, 2026
    Manufacturer
    BEAVER-VISITEC INTERNATIONAL, INC
    Product Code
    HNN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVOLVES THE REPORT OF A DULL BLADE DURING USE OF PART 378228 - SLIT KNIFE 2.8MM ANGL SNGL BEV W/SAFETY (10/SP). MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE AFFECTED PRODUCT FOR EVALUATION; HOWEVER, NO PHYSICAL SAMPLES OR PHOTOGRAPHS WERE PROVIDED BY THE CUSTOMER. AS A RESULT, THE REPORTED CONDITION COULD NOT BE CONFIRMED THROUGH PRODUCT EXAMINATION. A COMPREHENSIVE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE ASSOCIATED LOT CONFIRMED THAT THE PRODUCT WAS MANUFACTURED, INSPECTED, AND RELEASED IN ACCORDANCE WITH APPROVED SPECIFICATIONS AND ESTABLISHED PROCEDURES. ALL REQUIRED DOCUMENTATION, INCLUDING MANUFACTURING RECORDS, INSPECTION ACTIVITIES, SIGNATURES, AND DATES, WAS COMPLETE. NO DEVIATIONS, DISCREPANCIES, OR ANOMALIES WERE IDENTIFIED DURING THE REVIEW. IN ADDITION, CURRENT MANUFACTURING AND INSPECTION CONTROLS (FI-245-750MX, AP-100-294MX, AND IFM201253MX) WERE VERIFIED AND CONFIRMED TO HAVE BEEN EXECUTED AS REQUIRED. A REVIEW OF THE QUALITY SYSTEM RECORDS IDENTIFIED CAPA-00147, WHICH ADDRESSES COMPLAINTS RELATED TO DULL BLADES IDENTIFIED THROUGH BROADER PPM PERFORMANCE MONITORING AND TREND ANALYSIS. BASED ON THE AVAILABLE INFORMATION, NO EVIDENCE WAS FOUND INDICATING A MANUFACTURING DEFECT, PROCESS DEVIATION, OR QUALITY SYSTEM FAILURE ASSOCIATED WITH THE REPORTED LOT. THE REPORTED ISSUE COULD NOT BE VERIFIED DUE TO THE ABSENCE OF RETURNED PRODUCT, AND THE FAILURE MODE IS ALREADY BEING ADDRESSED THROUGH THE ONGOING CAPAINVESTIGATION. THEREFORE, NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS SPECIFIC TO THIS COMPLAINT ARE REQUIRED, AND THE COMPLAINT WILL CONTINUE TO BE MONITORED THROUGH ROUTINE COMPLAINT TRENDING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THE COMPLAINT CONCERNS A SAFETY KNIFE (PRODUCT 378228, LOT 6080873) REPORTED BY AN EXPERIENCED USER AS BEING SIGNIFICANTLY BLUNT COMPARED TO OTHER LOTS. THE DEVICE WAS USED DURING SURGERY, AND THE USER REPORTED THAT SUTURING WAS REQUIRED AS A RESULT OF THE DEVICE PERFORMANCE, INDICATING THAT THE DULL CUTTING EDGE CONTRIBUTED TO UNINTENDED TISSUE DAMAGE DURING THE PROCEDURE. BASED ON THE INFORMATION AVAILABLE, THE EVENT CAUSED TISSUE DAMAGE THAT REQUIRED UNPLANNED MEDICAL INTERVENTION. ALTHOUGH THE INJURY WAS DESCRIBED AS SUPERFICIAL, THE NEED FOR SUTURING CONSTITUTES AN UNPLANNED SURGICAL INTERVENTION BEYOND THE INTENDED PERFORMANCE OF THE DEVICE. THEREFORE, THE EVENT MEETS THE DEFINITION OF A SERIOUS DETERIORATION IN THE PATIENT'S STATE OF HEALTH AND WAS DEEMED REPORTABLE TO FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274758 SLIT KNIFE 2.8MM ANGL SNGL BEV W/SAFETY (10/SP) SLIT KNIFE 2.8MM ANGL SNGL BEV W/SAFETY (10/SP) HNN BEAVER-VISITEC INTERNATIONAL, INC N/A 6080873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention