VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD OTV-S7H-NRecalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7H-N VISERA CAM HEAD, ANGLED TYPE," · Class 2
All models of VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Visera angled camera head for laparoscopic surgery has 107 reports, no deaths and 1 injury. Many reports describe poor image quality, no picture at all, or a picture that flickers, shows lines, or turns red and green, and some describe a camera head that leaks or has a broken coating. 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
- 107
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 04953170141584), received between Dec 10, 2021 and Aug 26, 2026 — classified as 1 injury, 106 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (41 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
- Poor Quality Image41
- No Display/Image25
- Erratic or Intermittent Display10
- Break6
- Display or Visual Feedback Problem5
- Leak/Splash5
- Loose or Intermittent Connection5
- Detachment of Device or Device Component4
Patient problems
- No Clinical Signs, Symptoms or Conditions106
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456937 ↗MalfunctionDec 9, 2025Connection Problem; Connection Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23756017 ↗MalfunctionOct 29, 2025Fluid/Blood Leak; Image Display Error/Artifact; Fluid/Blood Leak; Image Display Error/Artifact
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE CAMERA HEAD HAD LINES IN THE IMAGE DUE TO A FAULTY CHARGED COUPLED DEVICE AND EXPERIENCED A LEAK. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23416576 ↗MalfunctionApr 24, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE EXPERIENCED AN UNCLEAR IMAGE DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21902047 ↗MalfunctionApr 23, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGE OF THE SUBJECT DEVICE WAS RED/GREEN, GRAINY AND FLICKERED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 21894768 ↗MalfunctionMar 18, 2025Fracture; Fracture
IT WAS REPORTED THAT THE COATING OF THE SUBJECT DEVICE WAS BROKEN. THE EVENT OCCURRED DURING SET UP / INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21637007 ↗MalfunctionJan 7, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD EXPERIENCED CLOUDY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21097365 ↗MalfunctionDec 9, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THAT DURING THE LAPAROSCOPIC PROCEDURE. THE SUBJECT DEVICE EXPERIENCED AN IMAGE BLACKOUT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20878077 ↗MalfunctionOct 22, 2024Break; Break
IT WAS REPORTED THAT THE CAMERA HEAD HAD A BROKEN CABLE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509760 ↗MalfunctionOct 17, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE CAMERA HEAD HAD A HOLE IN THE CORD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20477619 ↗MalfunctionOct 11, 2024Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem
IT WAS REPORTED THAT THE CAMERA HEAD OF THE SUBJECT DEVICE WAS BROKEN, AND AN IMAGE INTERFERENCE WAS ALSO OBSERVED. THE ISSUE WAS IDENTIFIED PRIOR TO A THERAPEUTIC LAPAROSCOPIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITHOUT DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20431547 ↗MalfunctionOct 10, 2024Poor Quality Image; Poor Quality Image
THE ISSUE WAS FOUND DURING THE MIDDLE OF TREATMENT OF A KNEE ARTHROSCOPIC SURGERY THAT WAS COMPLETED WITH A SIMILAR DEVICE WITHOUT ANY DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416277 ↗MalfunctionOct 3, 2024Loose or Intermittent Connection; Poor Quality Image; Loose or Intermittent Connection; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE DISPLAYED AN ABNORMAL IMAGE AND THAT THERE WAS POOR COMPONENT CONNECTION. THE ISSUE WAS FOUND DURING PREPARATION FOR A DIAGNOSTIC LAPAROSCOPE WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20364313 ↗MalfunctionOct 2, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE HAD AN ABNORMAL IMAGE. THE EVENT OCCURRED DURING AN UNSPECIFIED PROCEDURE THAT WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353498 ↗MalfunctionSep 26, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE CAMERA HEAD IMAGE HAD HORIZONTAL STRIPES. THE ISSUE OCCURRED DURING CLEANING AND DISINFECTION AFTER A DIAGNOSTIC ENDOSCOPY EXAMINATION. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20310815 ↗MalfunctionSep 16, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THAT DURING CLEANING AND DISINFECTION, THE SUBJECT DEVICE HAD ABNORMAL IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20230571 ↗MalfunctionSep 16, 2024Disconnection; Disconnection
IT WAS REPORTED THE SUBJECT DEVICE HAD CABLE DISCONNECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20224483 ↗MalfunctionSep 12, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem
IT WAS REPORTED THE SUBJECT DEVICE HAD A ABNORMAL IMAGE. THE ISSUE WAS IDENTIFIED DURING CLEANING AND DISINFECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20205956 ↗MalfunctionAug 28, 2024Degraded; Material Split, Cut or Torn; Degraded; Material Split, Cut or Torn
IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE SUBJECT DEVICE CABLE UNIT METAL PART WAS EXPOSED. AND THE COVER GLASS WAS DETERIORATED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091808 ↗MalfunctionAug 22, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: IMAGE DISAPPEAR (NO IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20039562 ↗MalfunctionAug 22, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD HAD AN IMAGE MALFUNCTION. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC HYSTEROSCOPY EXAMINATION THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20032299 ↗MalfunctionAug 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT DURING CLEANING AND DISINFECTION FOR A DIAGNOSTIC HYSTEROSCOPY PROCEDURE, THE CAMERA HEAD HAD AN IMAGE FLICKER. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME THE ISSUE WAS IDENTIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19962294 ↗MalfunctionAug 5, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE WATER TIGHTNESS IS LOST, AND A CUT ON CABLE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19905668 ↗MalfunctionJul 26, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE CAMERA HEAD FREQUENTLY HAD IMAGE FLICKER. THE MALFUNCTION OCCURRED PRIOR TO A THERAPEUTIC PROCEDURE FOR PLASMAKINETIC RESECTION. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839817 ↗MalfunctionJul 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE CAMERA HEAD SCREW OF FIXING SCOPE FELL OFF. THEN EVENT OCCURRED DURING CLEANING AND DISINFECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19773245 ↗
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-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page