Water-resistant cap MH-553Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170286438), received between Mar 24, 2023 and May 20, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT THE WATER-RESISTANT CAP METAL PIN IS BROKEN OFF ON THE METAL ADAPTER. THE ISSUE OCCURRED DURING AN UNKNOWN EVENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19354501 ↗
• InjuryMar 24, 2023Leak/Splash; Leak/Splash

  "THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A THERAPEUTIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SURGICAL PROCEDURE, WATER DAMAGE WAS FOUND DURING USE OF THE EVIS EXERA II DUODENOVIDEOSCOPE. THE ENDOSCOPE WAS INSPECTED PRIOR TO USE AND THE CUSTOMER REPORTED THAT WATER WAS INSIDE THE CAP DESIGNED TO PROTECT THE SCOPE FROM WATER. THE DEVICE WAS WORKING WHEN INITIAL PLUGGED IN, HOWEVER, THE PROCEDURE WAS ABORTED DUE TO THE LACK OF VISIBILITY WITH THE ENDOSCOPE. NO INFORMATION WAS PROVIDED IF THE PATIENT WAS UNDER ANESTHESIA AND IF THE PROCEDURE WAS EXTENDED DUE TO THE EVENT. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT REQUIRES TWO REPORTS: (B)(6): TJF-Q180V. (B)(6): MH-553. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER: (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 16616376 ↗