BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 23200993 · Received October 2, 2025

    Report

    Report Number
    8043817-2025-00007
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 2, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT WAS REPORTED AS A PRODUCT PROBLEM BECAUSE THE ISSUE INVOLVED A TEAR IN THE STERILE DRAPE, WHICH CONSTITUTES A DEVICE MALFUNCTION. ALTHOUGH THE PATIENT DEVELOPED A POSTOPERATIVE INFECTION REQUIRING A DAIR PROCEDURE, THE AVAILABLE INFORMATION DOES NOT ESTABLISH A CAUSAL RELATIONSHIP BETWEEN THE DRAPE TEAR AND THE INFECTION. POSTOPERATIVE INFECTIONS CAN OCCUR FOR MULTIPLE REASONS UNRELATED TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A TOTAL KNEE REPLACEMENT (TKR) PROCEDURE UTILIZING THE VELYS ROBOTIC SYSTEM, THE PLASTIC COVER OF THE ROBOTIC SAW REPORTEDLY BROKE, RESULTING IN A POTENTIAL CONTAMINATION OF THE SURGICAL FIELD. THE CUSTOMER INDICATED THAT THIS INCIDENT MAY HAVE CONTRIBUTED TO AN EARLY POSTOPERATIVE INFECTION. FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED AN INFECTION THAT REQUIRED A DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION (DAIR) PROCEDURE. BASED ON THE INFORMATION PROVIDED, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED DEVICE ISSUE AND THE INFECTION HAS NOT BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2623474 MICROTEK VELYS¿ DEVICE STERILE DRAPE PUI MICROTEK MEDICAL LLC 4515-70-018 2494LR5100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown