Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. GA Health Company Limited, FSN-QA-FSCA-2020-0001, Andorate® / PEXTAX Disposable Endoscope Valves Set (GAR004)

   GA Health Company Ltd. became aware that suction valve from Andorate® disposable endoscope valves set was sticky and/or broken ...

   Waarschuwing | 06-11-2020

3. Boston Scientific Corporation, 92556729-FA, Captivator/Captiflex Single-Use Polypectomy Snare

   BSC heeft een potentieel probleem opgemerkt bij het wegsnijden en verwijderen van poliepen bij gebruik van deze lots/batches.

   Waarschuwing | 06-07-2020

4. Field Safety Notice: Teleflex Medical, Percuvance® percutaan operatiesysteem

   Bij sommige van de teruggeroepen producten is mogelijk de stevigheid van de verbinding tussen de schacht en de instrumenttip ...

   Waarschuwing | 20-07-2017

5. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY25-EMEA-01-FY23-OSTA-14-InstaClear Sheath, INSTACLEAR SHEATH

   Olympus is taking this corrective action after investigating a complaint for an InstaClear Sheath (Model # LCS4K30BTOL) in which ...

   Waarschuwing | 08-05-2024

6. 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

7. Olympus Medical Systems Corporation, QIL FY24-EMEA-20-FY24-OMSC-20-GIF-1TH190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

   As a result of testing, Olympus discovered EOG sterilization failures in which the GIF-1TH190 failed to achieve sterilization ...

   Waarschuwing | 15-12-2023

8. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-32-FY24-OSTA-12, SOLTIVE Single-use Laser Fibers

   Olympus conducted an internal review of the SOLTIVE Single-use Fibers and identified inconsistencies in the IFU. Olympus is ...

   Waarschuwing | 14-12-2023

9. TROKAMED GmbH, 2023 VIG 105233 Morcellator, Griffmodul V2.0 5-times-use Morcellator System

   In rare cases, the Cutting Module may continue to rotate even though the activation switch on the Grip Module has been released.  

   Waarschuwing | 11-07-2023

10. Medtronic FA1259 - TruClear Hysteroscopic Tissue Removal System Control Unit

    Het doel van deze brief is u ervan op de hoogte te stellen dat Medtronic een vrijwillige terugroepactie onderneemt voor de ...

    Waarschuwing | 20-06-2022