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BfArM publishes Intuitive Surgical field safety notice for S. Monopolar Curved Scissors Tip

🇩🇪 BfArM field safety notices · Fri 06 Nov 2026

Germany's regulator has listed an urgent field safety notice from Intuitive Surgical covering a surgical scissors tip, but details of the issue sit only in the manufacturer's attached advisory.

The German Federal Institute for Drugs and Medical Devices (BfArM) published an Urgent Field Safety Notice on 6 November 2026 from Intuitive Surgical, Inc. The notice concerns the S. Monopolar Curved Scissors Tip and is filed under reference 51607/26.

BfArM classes the entry under surgical equipment and anaesthesia-surgical equipment. The web listing does not describe the nature of the problem, the affected lots or serial numbers, or what users are being asked to do.

Instead, the regulator directs readers to the manufacturer's Advisory Notice, attached to the entry as a 197 KB PDF. BfArM notes that the file does not meet accessibility standards.

Field safety notices are issued by manufacturers when they take a field safety corrective action on a device already on the market, and national authorities such as BfArM make them publicly available. Because the BfArM page carries no substantive detail, the scope and any required actions can only be confirmed from the manufacturer's document.

What it means for your team

  • Facilities using the S. Monopolar Curved Scissors Tip should obtain and read the full Advisory Notice from the BfArM entry (reference 51607/26) to confirm whether they are affected and what action is required.
  • Vigilance and quality teams should log the notice against their device records and document any internal assessment and response.
  • The BfArM listing gives no information on risk, affected batches or corrective measures, so no conclusions should be drawn beyond the manufacturer's own notice.

Official source: BfArM field safety notices ↗

Article written by VigiEye from the official source (BfArM field safety notices). AI-assisted; check the source before acting.

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