Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Megadyne Reusable Return Electrodes, FSN-2257672, Electrosurgical return electrode, reusable

   Hulpmiddelen voor het manipuleren en herstellen van lichaamsweefsels GMDN, Elektrode voor elektrochirurgisch diathermiesysteem ...

   Waarschuwing | 13-06-2023

2. Intervascular SAS, FSN-RC041, HEMAGARD KNITTED Bifurcated grafts

   Following an internal non-conformity report, a textile defect was identified within the body of an Hemagard Knitted bifurcated ...

   Waarschuwing | 13-06-2023

3. Xiros Ltd., FSN-2023-001, Suture/needle passer

   Xiros has received feedback that there have been a small number of instances where the CC-Hook instrument has deformed during ...

   Waarschuwing | 08-06-2023

4. Olympus Medical Systems Corporation, QIL FY24-EMEA-03-FY23-OMTA-35-HX-202-LRUR, SINGLE USE REPOSITIONABLE CLIP HX-202LR.UR

   Olympus has become aware of increased complaints on clip deployment occurring during clinical procedures, leading to hazardous ...

   Waarschuwing | 07-06-2023

5. TAG Medical Products Corporation LTD, 8043971-04.23.23-001-R, BETTA LINK SR KNOTLESS IMPLANT KIT

   The drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due ...

   Waarschuwing | 02-06-2023

6. Cook Endoscopy.Wilson Cook Medical Inc., 2023FA0006, Hemospray Endoscopic Hemostat

   Adhesion of the powder to the endoscope or endoscope to the tissue can result in delay in treatment, mucosal tear, perforation, ...

   Waarschuwing | 31-05-2023

7. Aesculap AG, FSCA 271, Tunneling instrument 600MM

   In some cases, the sealing of the sterile secondary packaging was not carried out in accordance with the process for the products ...

   Waarschuwing | 25-05-2023

8. Davol Inc. Subsidiary of C. R. Bard Inc, SUR-23-4657, Ventralight ST Mesh with Echo PS Positioning Sys

   BD heeft door klachten van klanten vastgesteld dat de e balloncomponent van het Ventralight ST-gaas met het Echo ...

   Waarschuwing | 22-05-2023

9. Teleflex Inc., EIF-000535, Weck Horizon HORIZON TI MICRO 6.CART 180.BOX

   Teleflex Medical Europe Limited start deze vrijwillige FSCA voor de bovengenoemde producten omdat de clipcartridges voor het ...

   Waarschuwing | 10-05-2023

10. DePuy Mitek, 2244073, Bioknotless Anchor

    This FSN is to alert users that applying bending force and/or bending force with impaction to the BIOKNOTLESS® Anchor Inserter ...

    Waarschuwing | 04-05-2023