HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10ERecalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7PROH-HD-10E CAM HEAD 1.0X 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 autoclavable camera head is used with a laparoscope, a surgical telescope. Most of its 1,078 reports describe no image appearing, and many describe poor image quality or an unstable display. The reports include no deaths and no injuries. 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
- 1,086
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,086 adverse event reports that list this exact device (DI 04953170252914), received between Apr 1, 2020 and Sep 29, 2026 — classified as 1,086 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (567 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/Image567
- Poor Quality Image274
- Erratic or Intermittent Display61
- Material Split, Cut or Torn49
- Leak/Splash29
- Communication or Transmission Problem24
- Break23
- Connection Problem21
Patient problems
- No Clinical Signs, Symptoms or Conditions1,047
- No Patient Involvement22
- No Consequences Or Impact To Patient17
- Insufficient Information2
- No Information1
Recent adverse event reports
The 25 most recent of 1,086 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Erratic or Intermittent Display; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934342 ↗MalfunctionSep 22, 2026Poor Quality Image
The customer reported poor image during inspection for use involving an Olympus camera head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856420 ↗MalfunctionSep 18, 2026Gas/Air Leak
The customer returned the Camera Head, which is an Olympus asset with no reported complaint. During the evaluation of the device, a failed leak test was observed. The Service Repair Technician indicated that the most likely cause of the failed leak test was component failure. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50817451 ↗MalfunctionSep 15, 2026Poor Quality Image
The customer returned the camera head¿which is an Olympus asset with no reported complaint. During the evaluation of the device, the service team identified a noisy image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778559 ↗MalfunctionSep 14, 2026Poor Quality Image
The customer reported image during an Inspection for use involving an Olympus autoclave camera head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50759488 ↗MalfunctionSep 10, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716747 ↗MalfunctionSep 9, 2026No Display/Image
The customer reported no picture when camera plugged, involving an Olympus camera head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50682519 ↗MalfunctionSep 8, 2026No Display/Image
The customer reported no image with an Olympus camera head. There was no patient harm reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50671608 ↗MalfunctionAug 30, 2026No Display/Image; Poor Quality Image; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50512548 ↗MalfunctionAug 19, 2026Device Emits Odor
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325282 ↗MalfunctionAug 19, 2026Break; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50325061 ↗MalfunctionAug 11, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209345 ↗MalfunctionAug 10, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50197683 ↗MalfunctionAug 10, 2026Image Display Error/Artifact
The customer reported a static on image involving an Olympus Camera Head. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192643 ↗MalfunctionAug 6, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50157803 ↗MalfunctionAug 5, 2026Break; No Display/Image; Display or Visual Feedback Problem; Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145206 ↗MalfunctionJul 29, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070319 ↗MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057962 ↗MalfunctionJul 8, 2026Poor Quality Image
THE CUSTOMER REPORTED POOR IMAGE QUALITY, SPECIFICALLY A POOR COLOR IMAGE ON THE SCREEN, DURING INSPECTION FOR USE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25750506 ↗MalfunctionJun 29, 2026No Display/Image; Key or Button Unresponsive/not Working
THE CUSTOMER REPORTED CAMERA CORD NOT WORKING AND IMAGE NOT DISPLAYED INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659645 ↗MalfunctionJun 18, 2026Leak/Splash; Poor Quality Image
THE CUSTOMER RETURNED THE CAMERA HEAD, WITH NO REPORTED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, IMAGE WAS DISTORTED AND LEAK TEST WAS FAILED. THE SERVICE REPAIR TECHNICIAN ASSESSED THE CONDITION AND DETERMINED THE CABLE WAS FAULTY AND THERE WAS AIR/WATER LEAKAGE IN THE CABLE. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25555465 ↗MalfunctionJun 16, 2026Poor Quality Image
THE CUSTOMER REPORTED POOR IMAGE DURING A SET UP INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25523329 ↗MalfunctionJun 10, 2026Poor Quality Image
THE CUSTOMER REPORTED THE IMAGE TURNED GREEN AND DISTORTED WITH AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25461943 ↗MalfunctionJun 3, 2026Poor Quality Image
THE CUSTOMER REPORTED PICTURE WOULD NOT FOCUS INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25385250 ↗MalfunctionJun 2, 2026No Display/Image
THE CUSTOMER RETURNED THE CAMERA HEAD, WHICH IS AN OLYMPUS ASSET WITH SEPARATE CASE. DURING THE EVALUATION OF THE DEVICE, NO IMAGE WAS OBSERVED. THE SERVICE REPAIR TECHNICIAN INDICATED THAT THE MOST LIKELY CAUSE OF THE NO IMAGE WAS DUE TO FAULTY CHARGED COUPLED DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361836 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
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- 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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