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Priority review Notice Amended Final

Electric Scalpel HF Bipolar Cable Safety Information

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Detected March 27th, 2026
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Summary

The ANSM has issued a safety alert regarding an action taken by Olympus Winter & IBE GmbH concerning their electric scalpel HF bipolar cable. Healthcare facilities have been informed of this safety action, registered under number R2607994.

What changed

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety information notice regarding an action implemented by Olympus Winter & IBE GmbH concerning their electric scalpel HF bipolar cable. This action is registered with the ANSM under number R2607994. Healthcare facilities that are users of this equipment have been directly notified by Olympus.

Healthcare providers using the affected Olympus electric scalpel HF bipolar cable must review the safety information and the direct communication from Olympus Winter & IBE GmbH. For specific questions or to understand the precise nature of the safety action and any required steps, users should contact Olympus directly. The notice does not specify a compliance deadline but indicates a safety action is underway.

What to do next

  1. Review safety information from ANSM and Olympus Winter & IBE GmbH.
  2. Contact Olympus directly for specific questions regarding the safety action.

Source document (simplified)

A+ A-

Information n° R2607994 destinée aux établissements de santé L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Olympus Winter & IBE GmbH.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607994. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Olympus Winter & IBE GmbH (27/03/2026)

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
ANSM
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive
Document ID
Information n° R2607994

Who this affects

Applies to
Healthcare providers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Safety
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Product Safety Healthcare Operations

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