Quality & complianceOfficial

Olympus extends HF cable safety notice to 19 more models after burn complaint

🇳🇱 IGJ · Thu 29 Oct 2026

Olympus Winter & Ibe says 19 further monopolar and bipolar HF cable models may share a defect linked to a minor burn; the Dutch inspectorate IGJ has published the notice.

The Dutch health inspectorate IGJ has published a field safety notice from Olympus Winter & Ibe GmbH covering monopolar HF cables, HiQ bipolar HF cables and the Versapoint connector cable. The notice is dated 20 October 2026.

The issue began with a complaint about a thermal incident involving HF cable WA00014A, which caused a minor burn. Olympus's investigation found that the cable had been used for longer than the service life given in its instructions for use and had not been inspected before use. According to the notice, this led to wear of the insulation, corrosion and defects.

Olympus issued a safety notice for WA00014A in March 2026. It has since identified 19 other models that could develop the same defect, and the new notice addresses those models.

The company found 60 complaints that may relate to thermal incidents with the 19 models over the past four years. It reports that none involved serious injury.

The text published by IGJ does not set out the specific corrective actions requested of users. Those details are in the manufacturer's 13-page PDF notice, which the inspectorate has made available for download.

What it means for your team

  • Quality and device-safety teams at hospitals and distributors should check the full Olympus notice to see which of the 19 additional cable models are affected and what action is required.
  • The investigation points to use beyond the stated service life and no pre-use inspection, so reviewing cable inspection and replacement routines against the instructions for use is worthwhile.
  • Vigilance teams may want to compare their own complaint and incident records for these cables with the 60 possibly related complaints Olympus reported over four years.

Official source: IGJ ↗

Article written by VigiEye from the official source (IGJ). AI-assisted; check the source before acting.

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