DeRoyal 89-9338Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00749756927864), received between Nov 13, 2018 and Jan 11, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Arcing” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Oct 3, 2024Open, Classified

   DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.

   Z-0306-2025 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 11, 2019Electrical /Electronic Property Problem; Arcing; Electrical /Electronic Property Problem; Arcing

  A CONVENIENCE KIT CONTAINED A CAUTERY PENCIL THAT MALFUNCTIONED DURING USE AND REPORTEDLY HAD AN ELECTRICAL ARC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8239717 ↗
• MalfunctionNov 13, 2018Electrical /Electronic Property Problem; Arcing; Electrical /Electronic Property Problem; Arcing

  A CONVENIENCE KIT CONTAINED A CAUTERY PENCIL THAT ARCED DURING USE. IT WAS CONNECTED TO A BOVIE GENERATOR. NO INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8063734 ↗