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MICROTEK 1 (UDI 00748426046287)Recalls & reported problems

Microtek Medical LLC · INTRAOPERATIVE ANGLED PROBE COVER, 5" X 96" LATEX FREE W/GEL, 20-PACK · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00748426046287), received between Dec 23, 2019 and Dec 23, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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

Device problems

  • Material Puncture/Hole1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionDec 23, 2019Material Puncture/Hole; Material Puncture/Hole

    IT WAS REPORTED THAT DURING AN INTRAOPERATIVE ULTRASOUND OF A PATIENT'S LEFT CAROTID ARTERY, THE PROBE TRANSDUCER CAME THROUGH THE DRAPE. THIS WAS CONSIDERED A BREAK IN STERILE TECHNIQUE. IT WAS UNKNOWN IF INJURY OCCURRED TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9510796 ↗

Other Drape, surgical devices

All Drape, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.