BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SNOWDEN-PENCER

    MDR report key: 22467294 · Received July 10, 2025

    Report

    Report Number
    1923569-2025-00010
    Event Type
    Malfunction
    Date Received
    July 10, 2025
    Date of Event
    April 1, 2025
    Report Date
    July 10, 2025
    Manufacturer
    STERIS CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    STERIS HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT HOWEVER, THE USER FACILITY HAS NOT RESPONDED. WITHOUT THE RETURN AND EVALUATION OF THE DEVICE, THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT 1923569-2025-00010 A LOT NUMBER WAS INCORRECTLY PROVIDED. THE LOT NUMBER FOR THE SUBJECT EVENT IS UNKNOWN. UDI RELATED DATA CLARIFICATION - THE LOT/SERIAL NUMBER IS UNKNOWN; THEREFORE, THE APPLICABLE PRODUCTION IDENTIFIERS WERE NOT INCLUDED IN THE MDR.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED VIA MEDWATCH # (B)(4), "DURING SURGICAL PROCEDURE REPAIRING INGUINAL HERNIA, A SNOWDEN LAPAROSCOPIC GRASPER MALFUNCTIONED AND BROKE WHILE INSERTING HERNIA MESH. THE BROKEN PIECE WAS REMOVED FROM TROCAR, MESH WAS REPLACED WITH NEW MESH, AND IRRIGATION FLUID WAS ALSO REPLACED. AN XRAY WAS PERFORMED IN OR BEFORE INCISIONAL CLOSURE TO CONFIRM THERE WERE NO RETAINED PIECES OF THE GRASPER IN THE PATIENT'S ABDOMEN. WET READ OF XRAY WAS CONDUCTED BY RADIOLOGIST-HE CONFIRMED THERE WERE NO RETAINED FOREIGN OBJECTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316514 SNOWDEN-PENCER DIAMOND-LINE GRASPER FLAT NOSE GEI STERIS CORPORATION SP90-6271 (10)C23

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown