General Purpose Probe Cover Kit 1020Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841912104048), received between Jan 27, 2020 and Jan 27, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionJan 27, 2020Material Puncture/Hole

  ACCORDING TO THE ORIGINAL REPORTER FROM (B)(6) HOSPITAL, THE SURGICAL TEAM HELD OPEN A STERILE PROBE COVER SO THAT IT COULD BE INSERTED A TRANSTHORACIC ULTRASOUND PROBE. THE PROBE WAS INSERTED AND THE SURGEON BEGAN TO PERFORM AN EPICARDIAL ECHOCARDIOGRAM PROCEDURE. AFTER THE SURGEON STARTED TO USE THE PROBE, HE NOTICED A SMALL HOLE IN THE PROBE COVER, AND THE SALINE LEAKED OUT INTO THE STERILE FIELD. HE PROMPTLY HANDED BACK THE PROBE AND COVER; A NEW COVER WAS THEN USED WITHOUT INCIDENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9633668 ↗