MICROTEK 1 (UDI 00748426092437)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00748426092437), received between Feb 28, 2023 and Sep 16, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (1 report).

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.

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.

• MalfunctionSep 16, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT MICROSCOPE DRAPE WAS OPENED TO THE FIELD. AS SCRUB TECH WAS PICKING UP SUPPLIES AND ORGANIZING SHE FOUND A HAIR STUCK INSIDE THE MICROSCOPE DRAPE. THIS WAS IMMEDIATELY REMOVED AND OPERATING ROOM TEAM BROKE DOWN THE STERILE FIELD BECAUSE OF POSSIBLE CONTAMINATION. NO PATIENT INJURY, INFECTION, OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17762162 ↗
• MalfunctionFeb 28, 2023Material Integrity Problem; Material Integrity Problem

  IT WS REPORTED THAT DURING THE PROCEDURE, THE PROTECTIVE PLASTIC PIECE WHICH COVERS THE LENS OF THE MICROSCOPE WAS DISCOVERED LOOSE IN THE MICROSCOPE DRAPE. THE LENS OF THE MICROSCOPE WAS UNCOVERED FACING THE PATIENT. NO PATIENT INJURY, INFECTION OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453195 ↗