Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

145 publicaties over Waarschuwingen van fabrikanten medische hulpmiddelen

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  1. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-36-FY24-OSTA-06, SOLTIVE SuperPulsed Laser System

    As part of Olympus’ post market surveillance of Soltive Laser use, including a review of customer complaints and adverse events, ...

    Waarschuwing | 27-03-2024

  2. Coloplast A/S, FSCA_20240223_Ureteral dilator, Ureteral Dilator (Ch/Fr 12-14, length 48 cm)

    In de faciliteit van Coloplast is bij sommige urethraledilatorproducten een mogelijk steriliteitsprobleem ontdekt. Dit probleem ...

    Waarschuwing | 26-03-2024

  3. Unimax Medical Systems, Inc., FCA-EP24001, Detachable EndoRetrieval Pouch

    The mechanism of the listed article number operates in a way that the tube within detaches during the removal process. If the ...

    Waarschuwing | 18-03-2024

  4. Olympus Medical Systems Corporation, QIL FY24-EMEA-40-FY24-OMSC-36, Single Use Electrosurgical Knife

    Olympus's investigation has identified that deterioration of the cutting knife can contribute to tip breakage during use. ...

    Waarschuwing | 14-03-2024

  5. Intuitive Surgical, Inc., ISIFA2024-02-R, SureForm45/60, Cannula Seal, Arm Drape, Obturator

    Tot onze spijt moeten wij u mededelen dat Intuitive zich ervan bewust is geworden dat bepaalde partijen van de volgende producten ...

    Waarschuwing | 07-03-2024

  6. Covidien IIc, FA1398, Auto Suture™ Structural Balloon Trocar, Auto Suture™ Blunt Tip Trocar

    We hebben meldingen ontvangen van voorvallen met betrekking tot de Covidien Auto Suture™ structurele trocar met ballon en Auto ...

    Waarschuwing | 07-03-2024

  7. Ace Medical Devices PVT LTD, AFSCA.01.2023-00, Ace Bladder Evacuator

    Bladder Rupture which may lead to patient/user death. Rare but Potential complication associated with the use of Bladder ...

    Waarschuwing | 26-01-2024

  8. Gyrus ACMI, Inc., SG PK CUTTING FORCEPS, 5MM, 33CM. Olympus

    The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

    Waarschuwing | 23-01-2024

  9. Gyrus ACMI, Inc., TFL Fiber Cleaver, TFL Fiber Stripper. Olympus

    Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a ...

    Waarschuwing | 23-01-2024

  10. Gyrus ACMI Inc, SOLTIVE Single-use Laser Fibers

    A breached sterile pouch seal on the 200 Micron TFL Ball Tip Single-Use  SOLTIVE Laser Fiber can lead to the potential harms of ...

    Waarschuwing | 09-01-2024