HD CAMERA HEAD OTV-S7ProH-HD-L08ERecalls & reported problems

Olympus Medical Systems Corp. · "OTV-S7PROH-HD-L08E HD URO CAMERA" · Class 2

Quick summary

This Olympus HD urology camera head has 1,410 FDA adverse event reports, with 1 injury, 1,409 malfunctions and no deaths. The reports mostly describe no image on the display, poor image quality, and the camera head failing leak tests, with some describing torn material or loose connections. 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: 1,424
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1,424 adverse event reports that list this exact device (DI 04953170268267), received between Nov 10, 2020 and Sep 28, 2026 — classified as 1 injury, 1,423 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (542 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

No Display/Image542
Poor Quality Image333
Material Split, Cut or Torn104
Leak/Splash76
Loose or Intermittent Connection66
Break62
Erratic or Intermittent Display60
Gas/Air Leak51

Patient problems

No Clinical Signs, Symptoms or Conditions1,420
No Consequences Or Impact To Patient2
Insufficient Information1
No Patient Involvement1

Recent adverse event reports

The 25 most recent of 1,424 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 28, 2026Loose or Intermittent Connection; Poor Quality Image
The customer reported that the lock was wobbly and swiveling during reprocessing of an Olympus camera head. During the initial evaluation of the device, purple lines were observed on the image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923183 ↗
MalfunctionSep 24, 2026Gas/Air Leak
The customer returned the camera head, which is an Olympus asset with no reported complaint. During the initial evaluation of the returned device, a failed leak test was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885327 ↗
MalfunctionSep 22, 2026Failure to Power Up
The customer reported that, after plugging the device back in, it was not functioning during reprocessing involving an Olympus camera head. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856707 ↗
MalfunctionSep 22, 2026No Display/Image; Leak/Splash
The customer reported that the picture from Olympus Camera Head cut out during inspection for use. During the initial evaluation of the device, failed leak test was observed. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856370 ↗
MalfunctionSep 22, 2026Poor Quality Image
The customer reported that the Camera Head was not working during reprocessing. During the initial evaluation of the device, lines were showing on the image due to a faulty Charged Coupled Device were observed. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50849548 ↗
MalfunctionSep 15, 2026Poor Quality Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782214 ↗
MalfunctionSep 15, 2026No Display/Image
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781730 ↗
MalfunctionSep 11, 2026No Display/Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50742762 ↗
MalfunctionSep 10, 2026Detachment of Device or Device Component
The customer reported that coupler end popped right off during inspection for use involving an Olympus camera head. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715208 ↗
MalfunctionSep 8, 2026Poor Quality Image; No Device Output
The customer reported the camera head light won't turn on during Inspection for use. During the initial evaluation of the device it was observed, poor color image and faulty charged coupled device. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675276 ↗
MalfunctionSep 8, 2026Poor Quality Image
The customer reported the camera head had a separate issue. During the initial evaluation of the device it was observed, Black dead pixel showing on image. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50672140 ↗
MalfunctionSep 2, 2026Loose or Intermittent Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567975 ↗
MalfunctionAug 31, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50529031 ↗
MalfunctionAug 26, 2026Break; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50455567 ↗
MalfunctionAug 24, 2026Mechanical Problem; Gas/Air Leak
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50412670 ↗
MalfunctionAug 20, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50351393 ↗
MalfunctionAug 20, 2026No Display/Image; Gas/Air Leak
The customer reported the camera head image was lost. During the initial evaluation of the device had failed leak test was found. No patient involvement was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50335653 ↗
MalfunctionAug 19, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50324290 ↗
MalfunctionAug 19, 2026Gas/Air Leak; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50315840 ↗
MalfunctionAug 18, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50311507 ↗
MalfunctionAug 18, 2026Leak/Splash
The customer returned the Camera head for a separate issue. However, during the initial evaluation of the device, a failed leak was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303424 ↗
MalfunctionAug 14, 2026Material Protrusion/Extrusion; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50246544 ↗
MalfunctionAug 7, 2026Leak/Splash; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50177233 ↗
MalfunctionAug 4, 2026Moisture Damage; Poor Quality Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129514 ↗
MalfunctionJul 29, 2026Material Fragmentation; Loose or Intermittent Connection; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070882 ↗

Device details

UDI-DI	`04953170268267`
Brand	HD CAMERA HEAD
Model	OTV-S7ProH-HD-L08E
Company	Olympus Medical Systems Corp.
Product code	FET · Endoscopic video imaging system/component, gastroenterology-urology
Class	Class 2
FDA submission	K083155
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 6, 2025

Device type (GMDN): Endoscope video camera

An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.