Midas Rex Legend DS1TD32LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000002503), received between Jul 28, 2022 and Jul 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

1 other recall cover devices cleared under the same FDA submission (K191597); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 28, 2022Vibration; Physical Resistance/Sticking; Vibration; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING THE ELECTRODE AND PROBE PLACEMENT PROCEDURE, THE DRILL BIT WAS VIBRATING, THIS CAUSED A HOLE TOO LARGE FOR THE VISUALIZE SKULL MOUNT LEAD PLACEMENT AND THE HOUSING WAS LOCKED. IT WAS REPORTED THAT PROCEDURE WAS DELAYED FOR 30 MINUTES TO ONE HOUR AND THE PATIENT WAS UNDER ANESTHESIA, SURGERY ABORTED AND WILL BE RESCHEDULED. DURING THE DELAY, ANOTHER INSTRUMENT SET WAS BROUGHT IN TO USE IN PROCEDURE. SURGEON CREATED A DIFFERENT PLAN/TRAJECTORY IN ORDER TO ATTEMPT TO PLACE ANOTHER LASER FIBER.

  Patient problems: Chemical Exposure

  MAUDE report 15120732 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191597. One submission often covers many models, so check the product and lot details in each record.

• Z-0417-2022 · Nov 9, 2021 · Open, Classified
  Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.