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SLIDE-ON® 224501Recalls & reported problems

Medtronic Xomed, Inc. · SHEATH 224501 20PK OLYMPUS ENF-V · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 20613994394600), received between Aug 8, 2023 and Aug 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (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

Device problems

  • Peeled/Delaminated1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 8, 2023Peeled/Delaminated; Peeled/Delaminated

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE VISERA RHINO-LARYNGOVIDEOSCOPE HAD A CRACK IN THE COATING OF THE SHEATH. THE ISSUE WAS OBSERVED DURING PREPARATION FOR USE ON A DIAGNOSTIC PROCEDURE. NO REPORTS OF PATIENT HARM WERE ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED TO OLYMPUS FOR A DEVICE EVALUATION AND FOUND THAT THE COATING FELL OFF DUE TO THE TEAR OF THE INSERTION PART. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17481904 ↗

Other NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices

All NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices →

Sources and updates

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