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