Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. 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

2. Gyrus ACMI, Inc. (Olympus Surgical Technologies America), QIL FY24-EMEA-26-FY24-OSTA-07, EZDilate Fixed Wire (Guided) Balloon

   Olympus is taking this recall action after investigating reported complaints about issues inflating, deflating and/or retrieving ...

   Waarschuwing | 07-12-2023

3. Olympus, QIL FY24-EMEA-19-FY24-OMSC-19, High Flow Insufflation Unit

   Olympus has become aware of patients experiencing complications from over insufflation, including arrythmias reported as “short ...

   Waarschuwing | 01-12-2023

4. Olympus Medical Systems Corporation, QIL FY24-EMEA-13-FY24-OMSC-02-TJF-Q190V-290V-170V, OLYMPUS TJF-Q190V/Q290V/Q170V DUODENOSCOPE

   Olympus is initiating this action after becoming aware of recent reports of infections and positive cultures. Olympus is ...

   Waarschuwing | 28-11-2023

5. Olympus Medical Systems Corporation, QIL FY24-EMEA-21-FY24-OMSC-26 CV-1500, EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500

   Olympus has received one complaint that the water delivery tube came in contact with the touch panel and the Air flow button was ...

   Waarschuwing | 02-11-2023

6. Cook Endoscopy-Wilson Cook Medical, Inc., 2023FA0009, Quantum TTC Biliary Balloon Dilator

   Cook Endoscopy/Wilson-Cook Medical, Inc. is initiating a voluntary removal of affected QBD devices from the market because they ...

   Waarschuwing | 02-11-2023

7. Stryker Endoscopy, RA2023-3234487, Safelight fiber optic cable

   Er bestaat kans op ontevredenheid van de gebruiker en letsel bij de patiënt, omdat het probleem kan zorgen voor een klinische ...

   Waarschuwing | 08-09-2023

8. Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0007, Fusion Lithotripsy Extraction Basket

   Er zijn afwijkende Fusion-extractievangnetjes voor lithotripsie vervaardigd en gedistribueerd. Deze afwijking in de vervaardiging ...

   Waarschuwing | 24-07-2023

9. Olympus Medical Systems Corporation, QIL FY24-EMEA-06-FY24-OMSC-04c, BF-Series Endoscopes

   Olympus has received complaints of endobronchial combustion during therapeutic procedures using lasers or argon plasma ...

   Waarschuwing | 21-07-2023

10. Karl Storz SE Co. KG, 23-0008, FIVE S 5.3x65 sterile for single use

    Within the revalidation of the sterilization process the revalidation failed.

    Waarschuwing | 12-07-2023