Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Coloplast FRGNY-2017-1009-AEBD35 - Duowire™ Bi-Flex voerdraad

   Er is geconstateerd dat bij gebruik, in met name urologische procedures, het risico bestaat dat bepaalde delen van de distale ...

   Waarschuwing | 16-10-2017

2. Intuitive Surgical Inc 2955842-07/14/16-010-R - IS4000 EndoWrist Stapler 45, IS4000 EndoWrist Stapler 30, IS4000 EndoWrist Stapler 30 Curved-Tip

   This recall follows from a field failure where the stapler remained clamped on tissue, even when the Stapler Release Kit was ...

   Waarschuwing | 03-11-2016

3. Covidien LLC Clearify Visualization 10/16 - Clearify Visualization System

   This Field Safety Corrective Action (FSCA) is being conducted due to the potential for compromise of the package resulting in a ...

   Waarschuwing | 07-10-2016

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. 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

6. 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

7. 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

8. 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

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. 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