AUTOCLAVABLE CAMERA HEAD OTV-S7H-NARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170141744), received between Apr 20, 2022 and Jul 22, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Poor Quality Image; Connection Problem; Poor Quality Image; Connection Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD CABLE PROBLEM AND IMAGE DISTORTION. THE ISSUE WAS IDENTIFIED DURING PREPARATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19801746 ↗
• MalfunctionApr 1, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE CAMERA HEAD HAD AIR LEAKAGE FROM THE CONNECTOR SECTION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19014092 ↗
• MalfunctionJan 22, 2024Crack; Material Split, Cut or Torn; Crack; Material Split, Cut or Torn

  THE CUSTOMER REPORTED TO OLYMPUS, THE CAMERA HEAD HAD A CRACK, WIRE WAS CUT. THERE WERE NO REPORTS OF PATIENT HARM OR INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556909 ↗
• MalfunctionJan 12, 2024Image Orientation Incorrect; Poor Quality Image; Image Orientation Incorrect; Poor Quality Image

  IT WAS REPORTED THE DEVICE HAD AN ISSUE OF "IMAGE DISTORTION WHEN MOVING" , REPAIR WAS REQUESTED. THERE WAS NO PATIENT IMPACT, NO HARM REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18505980 ↗
• MalfunctionNov 17, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE CAMERA HEAD A E315 SCOPE COMMUNICATION ERROR. THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18161250 ↗
• MalfunctionMay 5, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT THE IMAGE OF THE AUTOCLAVABLE CAMERA HEAD WAS NOT DISPLAYED. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16878367 ↗
• MalfunctionApr 20, 2022No Display/Image; No Display/Image

  THE USER FACILITY REPORTED THAT WHEN PREPARING THE SUBJECT DEVICE FOR USE DURING AN UNSPECIFIED PROCEDURE, THERE WAS NO IMAGE DUE TO A "SANDSTORM" ON THE DISPLAY. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164621 ↗