Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

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

   Intuitive is tot de ontdekking gekomen dat er bepaalde partijen verzonden zijn die over hun officiële vervaldatum waren.

   Waarschuwing | 04-04-2024

2. 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

3. 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

4. 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

5. 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

6. CooperSurgical, Origio® Sperm Wash Medium

   CooperSurgical has internally become aware of a non-conformity of Origo® Sperm Wash Media related to the low concentration of ...

   Waarschuwing | 22-02-2024

7. 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

8. KARL STORZ SE & Co. KG-23-0015, BEYER Antrum Punch, Antrum Punch, Sphenoid Punch, Sphenoid Punch, Sphenoid Punch, Galea Spring Hook, Uvula Retractor, Optical Biopsy and Grasping Forceps, Grasping Forceps, Optical Scissor, Working Insert with steering lever

   It was found that there is not insufficient evidence to show that the reprocessing method of the products was adequately ...

   Waarschuwing | 04-01-2024

9. 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

10. FSN-FSCA 272, Aesculap AG, Laparoscopic access

    We detected a non-conformity to the product specification of part number FF399R caused by a manufacturing deviation. The affected ...

    Waarschuwing | 10-07-2023