Documenten - Waarschuwingen van fabrikanten medische hulpmiddelen

1. Gyrus ACMI Inc., QIL FY24-EMEA-05-FY23-OSTA-17, UroPass Ureteral Access Sheath Set

   The investigation showed that reported breakages were associated with devices aged more than three years.

   Waarschuwing | 21-07-2023

2. MEDICREA INTERNATIONAL S.A., FSN-FA1335, GRANVIA-C, IMPIX ALIF, IMPIX ALIF S/A, IMPIX C+. IMPIX DLIF, IMPIX MANTA, IMPIX MANTA+, IMPIX S, IMPIX TLIF, PASS LP

   Tijdens een intern onderzoek ontdekte Medtronic de mogelijkheid van een productconformiteitsprobleem in de vorm van een gaatje in ...

   Waarschuwing | 18-07-2023

3. Smith & Nephew Medical Limited, C-2023-05, Secura No-Sting Skin-Prep.Barrier Film

   Productiefout die resulteert in de aanwezigheid van azijnzuur, wat een azijnachtige geur en mogelijke lichte huidirritatie ...

   Waarschuwing | 17-07-2023

4. 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

5. NVT GmbH, FSN-CAPA 23-10, ALLEGRA Transcatheter Heart Valve

   NVT has been informed that there has been a mix-up between an ALLEGRA THV 23 and an ALLEGRA THV 31.lf not identified prior to ...

   Waarschuwing | 11-07-2023

6. 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

7. VYGON, FSN-23 0203, Kocher forceps in delivery sets

   When Kocher forceps are used for clamping the umbilical cord, a permanent monitoring must be ensured to prevent them from ...

   Waarschuwing | 06-07-2023

8. SYMATESE, FSN-HEM/PAN-21-001-V2, PANGEN® and HEMOTESE®

   Several complaints have been registered by SYMATESE following a difficulty encountered when opening the external pouch of ...

   Waarschuwing | 27-06-2023

9. Medtronic Inc., FSN-FA1342, Durepair Dura Regeneration Matrix

   Medtronic was informed by the contract manufacturer (Integra LifeSciences Boston) that based on internal investigation they have ...

   Waarschuwing | 26-06-2023

10. Intuitive Surgical, Inc., ISIFA2023-02-R, Tip-Up Fenestrated Grasper

    Dit fabricageprobleem kan mogelijk resulteren in het (af)breken van het bovenste en/of onderste bekje.

    Waarschuwing | 16-06-2023