HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12ERecalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7PROH-HD-12E CAM HEAD 1.2X EYEPIECE" · Class 2
All models of HD AUTOCLAVABLE CAMERA HEAD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus HD camera head for surgical laparoscopes has 1,876 adverse event reports on record, with no deaths and 1 injury. Most reports describe no image on the screen, with others describing poor picture quality, a display that cuts in and out, and split or torn casings. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,886
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,886 adverse event reports that list this exact device (DI 04953170228834), received between Apr 7, 2020 and Sep 30, 2026 — classified as 1 injury, 1,885 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (1,022 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/Image1,022
- Poor Quality Image432
- Erratic or Intermittent Display135
- Material Split, Cut or Torn82
- Break52
- Loose or Intermittent Connection46
- Display or Visual Feedback Problem39
- Leak/Splash33
Patient problems
- No Clinical Signs, Symptoms or Conditions1,822
- No Patient Involvement33
- No Consequences Or Impact To Patient32
- Insufficient Information3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 1,886 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Leak/Splash; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954947 ↗MalfunctionSep 30, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952628 ↗MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949906 ↗MalfunctionSep 29, 2026Poor Quality Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935668 ↗MalfunctionSep 29, 2026Electrical /Electronic Property Problem; Poor Quality Image
The customer reported the camera head had a static that will not clear during reprocessing. During the initial evaluation of the device, it was observed that it was due to a faulty cable. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934110 ↗MalfunctionSep 21, 2026Poor Quality Image; Material Split, Cut or Torn
The customer reported crack on the screen during reprocessing involving an Olympus camera head. During initial evaluation it was observer, one lines on the screen. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843129 ↗MalfunctionSep 17, 2026No Display/Image
The customer reported black screen, no picture during an unknown event using an Olympus camera head. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797585 ↗MalfunctionSep 14, 2026No Display/Image
The customer reported no image during reprocessing involving an Olympus Camera Head. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50755854 ↗MalfunctionSep 8, 2026Erratic or Intermittent Display
The customer reported image noise when the cable was moved during a pre-use inspection with an Olympus camera head. No patients were involved.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50667780 ↗MalfunctionSep 7, 2026Poor Quality Image
During initial evaluation of the device the corrosion on the coupler unit was observed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50649728 ↗MalfunctionSep 1, 2026Failure to Clean Adequately
The customer returned the Camera Head for a separate issue. During the initial evaluation of the device, it was observed that the cable had a stain. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50552539 ↗MalfunctionAug 31, 2026Erratic or Intermittent Display; Device Emits Odor
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50529876 ↗MalfunctionAug 18, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307068 ↗MalfunctionAug 18, 2026No Display/Image; Loose or Intermittent Connection; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304574 ↗MalfunctionAug 10, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194038 ↗MalfunctionAug 7, 2026Leak/Splash; Poor Quality Image; Output Problem
The customer returned the Camera Head, which is an Olympus asset with no reported complaint. During the evaluation of the device, Image anomaly, Leakage test failed and Operation failure was found.was observed. There was no patient involvement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50181574 ↗MalfunctionAug 7, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175427 ↗MalfunctionAug 4, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50136566 ↗MalfunctionAug 3, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116621 ↗MalfunctionAug 3, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50113557 ↗MalfunctionJul 30, 2026Poor Quality Image
The customer reported bad image during inspection for use involving an Olympus camera head. There were no reports of patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50091927 ↗MalfunctionJul 28, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060663 ↗MalfunctionJul 27, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038942 ↗MalfunctionJul 20, 2026Poor Quality Image
THE CUSTOMER REPORTED FLICKERING IMAGE AND A RED LINE DURING DEVICE INSPECTION FOR USE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25882087 ↗MalfunctionJul 14, 2026Erratic or Intermittent Display; Electrical Shorting
THE CUSTOMER REPORTED A SHORT IN THE MIDDLE OF THE CORD AND SCREEN COMES IN AND OUT DURING A DIAGNOSTIC ENDOSCCOPIC CARPAL TUNNEL PROCEDURE INVOLVING AN OLYMPUS CAMERA HEAD. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812648 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
- VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD OTV-S7H-1D-L08EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery578 reports
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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