HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10QRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of HD AUTOCLAVABLE CAMERA HEAD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04953170252945), received between Sep 10, 2020 and May 13, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- No Display/Image7
- Poor Quality Image2
- Erratic or Intermittent Display1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Patient Involvement1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THE CAMERA HEAD HAD WATER DROP-LIKE SCRATCHES REFLECTED ON THE IMAGE. THE ISSUE WAS FOUND DURING PRE-USE INSPECTION FOR A THERAPEUTIC CARPAL TUNNEL SYNDROME PROCEDURE WHICH WAS COMPLETED WITH THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19297287 ↗MalfunctionNov 20, 2023No Display/Image; No Display/Image
THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS NO IMAGE DISPLAYED FROM THE CAMERA HEAD. THE ISSUE WAS FOUND DURING PREPARATION FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE, WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18169676 ↗MalfunctionAug 17, 2023No Display/Image; No Display/Image
THE CUSTOMER REPORTED TO OLYMPUS, THE HD AUTOCLAVABLE CAMERA HEAD VIDEO WAS NOT DISPLAYED. THE ISSUE WAS FOUND DURING PREPARATION FOR USE, THE INTENDED THERAPEUTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17568983 ↗MalfunctionSep 26, 2022No Display/Image; No Display/Image
THE FOLLOWING ADDITIONAL INFORMATION RECEIVED REGARDING THE REPORTED EVENT: THE ISSUE OF "COLOR BAR DISPLAY" OCCURRED BEFORE A PROCEDURE. THE TYPE OF PROCEDURE IS UNKNOWN. HOWEVER, IT WAS CONFIRMED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER CAMERA HEAD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15487080 ↗MalfunctionSep 2, 2022No Display/Image; No Display/Image
THE CUSTOMER REPORTED TO OLYMPUS THAT THE HD AUTOCLAVABLE CAMERA HEAD DOES NOT WORK. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15352480 ↗MalfunctionMay 7, 2022No Display/Image; No Display/Image
THE CUSTOMER REPORTED THAT HIS OLYMPUS HD AUTOCLAVABLE CAMERA HEAD WAS EXPERIENCING AN IMAGE ISSUE DURING USE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT ALL ANSWERS WERE UNKNOWN. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT NO IMAGE WAS APPEARING AT ALL DUE TO A FAULTY CHARGED COUPLED DEVICE UNIT. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE NO IMAGE EVENT CONFIRMED DURING THE DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316492 ↗MalfunctionFeb 7, 2022No Display/Image; No Display/Image
THE CUSTOMER REPORTED THAT HIS OLYMPUS HD AUTOCLAVABLE CAMERA HEAD WAS NOT PRODUCING AN IMAGE DURING USE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT ARE UNKNOWN. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13477059 ↗MalfunctionFeb 7, 2022Erratic or Intermittent Display; Erratic or Intermittent Display
THE CUSTOMER REPORTED THE HD AUTOCLAVABLE CAMERA HEAD HAS SUDDEN LOSS OF IMAGE. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13475085 ↗MalfunctionMay 26, 2021No Display/Image; No Display/Image
THE BIOMEDICAL TECHNICIAN AT THE USER FACILITY REPORTED, DURING PREPARATION FOR USE THE HIGH DEFINITION AUTOCLAVABLE CAMERA HEAD DID NOT WORK, THE IMAGE DOES NOT APPEAR. THERE WAS NO PATIENT INVOLVEMENT AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR CAMERA HEAD WITHOUT ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11883049 ↗MalfunctionSep 10, 2020Poor Quality Image; Poor Quality Image
A USER FACILITY REPORTED AN IMAGE PROBLEM EVERY TIME THEY MOVE THE PART THAT PLUGS INTO THE PROCESSOR. SOMETIMES THERE IS NO IMAGE AND LINES ON THE SCREEN. NO PATIENT INVOLVEMENT OR INJURY WAS REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.
Patient problems: No Patient Involvement
MAUDE report 10516386 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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