AUTOCLAVABLE CAMERA HEAD OTV-S7H-1NA-10E (UDI 04953170141775)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170141775), received between Oct 1, 2020 and Sep 6, 2023 — classified as 10 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (7 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, WHEN USING THE CAMERA HEAD, NO IMAGE IS DISPLAYED WHEN THE OPTICAL VIEWING TUBE IS CONNECTED. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17696018 ↗
• MalfunctionMay 24, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE AUTOCLAVABLE CAMERA HEAD WAS NOT WORKING. IT WAS ADDED THAT IT PRODUCED A STATIC, FLICKERING IMAGE. THIS OCCURRED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998870 ↗
• MalfunctionApr 26, 2023No Display/Image; No Display/Image

  IT WAS REPORTED TO OLYMPUS THAT A CAMERA HEAD HAD NO IMAGE. THE CAMERA WAS SWITCHED OUT TO COMPLETE THE THERAPEUTIC CYSTOSCOPY PROCEDURE. THERE WAS NO PATIENT INJURY OR ADVERSE EVENT REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820049 ↗
• MalfunctionApr 19, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE IMAGE WAS FLICKERING ON AND OFF ON THE AUTOCLAVABLE CAMERA HEAD. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766827 ↗
• MalfunctionMar 9, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE AUTOCLAVABLE CAMERA HEAD HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16518744 ↗
• MalfunctionJan 4, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, DURING PROCEDURE, THE IMAGE WITH THE AUTOCLAVABLE CAMERA HEAD FROZE. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO DELAY. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096955 ↗
• MalfunctionMay 26, 2022Erratic or Intermittent Display; Erratic or Intermittent Display

  THE CUSTOMER REPORTED TO OLYMPUS, THE AUTOCLAVABLE CAMERA HEAD VIDEO WAS DROPPING IN AND OUT DURING SET UP FOR AN UNKNOWN DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14508000 ↗
• MalfunctionDec 16, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  A USER FACILITY REPORTED TO OLYMPUS THAT THE IMAGE WAS FLICKERING. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13022868 ↗
• MalfunctionMay 25, 2021Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display; No Display/Image

  INTERMITTENT PICTURE, THE PICTURE CUTS OUT AND COMES BACK WHEN CABLE IS BEING ADJUSTED WAS REPORTED. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11879917 ↗
• MalfunctionOct 1, 2020No Display/Image; No Display/Image

  THE USER FACILITY REPORTED THAT THE SCREEN IS BLACK ON THE DEVICE. IT WAS REPORTED THAT THIS ISSUE WAS DISCOVERED DURING PREPARATION FOR USE SO THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10616778 ↗