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Precautions of Using the Sterilization Cap MAJ-1538Recalls & reported problems

Olympus Medical Systems Corp. · MAJ-1538 Sterilization Cap · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170233012), received between Apr 27, 2020 and Apr 27, 2020 — classified as 1 injury.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Injury1

Recent adverse event reports

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

  • InjuryApr 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT A NURSE OF THE USER FACILITY INJURED HIS OR HER FINGER WHEN HE OR SHE ATTACHED THE SUBJECT MAJ-1538 (STERILIZATION CAP) TO THE ENDOSCOPE LTF-S190-5 DURING REPROCESSING. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Patient problems: Injury

    MAUDE report 10000650 ↗

Other NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices

All NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) devices →

Sources and updates

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