VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD OTV-S7H-1NRecalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7H-1N 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 camera head is an angled camera used in laparoscopic surgery with the VISERA video system. Many of its 298 reports describe poor image quality or no image on the screen, along with damaged cables and housings. The reports mention no deaths and no injuries. Reports fell from 32 in the 12 months before to 16 in the latest 12 months. 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
- 300
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 04953170141614), received between Mar 31, 2021 and Sep 2, 2026 — classified as 300 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (105 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 Image105
- No Display/Image93
- Break20
- Leak/Splash18
- Material Split, Cut or Torn17
- Erratic or Intermittent Display14
- Gas/Air Leak8
- Component Missing6
Patient problems
- No Clinical Signs, Symptoms or Conditions299
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 300 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Poor Quality Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566258 ↗MalfunctionAug 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50432443 ↗MalfunctionAug 20, 2026Leak/Splash; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50359528 ↗MalfunctionAug 3, 2026Poor Quality Image; Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116498 ↗MalfunctionJul 27, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50038887 ↗MalfunctionJul 8, 2026Poor Quality Image
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE OLYMPUS REPAIR TECHNICIAN IDENTIFIED A LARGE DEAD PIXEL IN THE IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25753817 ↗MalfunctionJul 6, 2026Component Missing
THE CUSTOMER REPORTED THE PINS THAT YOU SQUEEZE TOGETHER THAT ATTACH TO THE SCOPE WERE TORN OFF OR MISSING DURING AN UNSPECIFIED PROCEDURE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25723513 ↗MalfunctionJun 2, 2026Crack; Material Split, Cut or Torn
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD STRAIN RELIEF WAS CRACKED, AND THE RUBBER PIECE WAS SPLIT DUE TO CUT ON CABLE BOOT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365403 ↗MalfunctionMay 27, 2026Material Split, Cut or Torn
THE CUSTOMER RETURNED CAMERA HEAD TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE CENTER IDENTIFIED DAMAGED CABLE INSULATION EXPOSING INNER METALS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25306930 ↗MalfunctionMay 23, 2026Break; No Display/Image
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TEAM INDICATES THAT NO IMAGE SHOWED ON THE SCREEN AND DAMAGE CABLE INSULATION METAL SHEATH WAS EXPOSED. IT WAS DETERMINED THAT THE CABLE INSULATION METAL SHEATH NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264755 ↗MalfunctionMay 23, 2026Material Split, Cut or Torn
THE CUSTOMER RETURNED THE CAMERA HEAD TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE CENTER IDENTIFIED DAMAGE TO THE CABLE INSULATION WITH THE METAL SHEATH EXPOSED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25264725 ↗MalfunctionMay 11, 2026Loose or Intermittent Connection; Poor Quality Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD LOOSE CONNECTION. LOOSE CORD AND PERIODIC PICTURE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134154 ↗MalfunctionApr 27, 2026Peeled/Delaminated
IT WAS REPORTED THAT THE CAMERA HEAD HAD WIRES ARE EXPOSED WHERE THE LIGHT MEETS THE CORD. THE ISSUE WAS FOUND DURING REPROCESSING OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25009465 ↗MalfunctionApr 7, 2026Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24809376 ↗MalfunctionApr 1, 2026Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD EXPERIENCED VERY BLURRY VISION. THIS ISSUE OCCURRED REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753808 ↗MalfunctionJan 2, 2026Poor Quality Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD IMAGE NOISE DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23942938 ↗MalfunctionDec 19, 2025Break; Break
IT WAS REPORTED THAT THE CAMERA HEAD EXHIBITED CORD RIPPED UNDER CAMERA BOOT AND THE OUTSIDE OF CORD FELT LIKE IT SLIDE TOO EASY AROUND CORE OF CORD. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23849878 ↗MalfunctionDec 11, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD NO PICTURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778501 ↗MalfunctionOct 17, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A POOR COLORED IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23324436 ↗MalfunctionOct 15, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING DEVICE EVALUATION THE CAMERA HEAD EXHIBITED IMAGE ABNORMALITY. THERE WERE NO REPORTS OF ANY PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23302211 ↗MalfunctionSep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SUBJECT DEVICE HAD THE ADAPTER SCREW SHEARED OFF. THE EVENT OCCURRED DURING SETUP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23089717 ↗MalfunctionJul 28, 2025Material Deformation; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMARA HEAD EXHIBITED A KINK AS WELL AS KNOT ON THE CABLE AND FAULTY CHARGED COUPLED DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22632263 ↗MalfunctionJun 19, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE DID NOT DISPLAY AN IMAGE. THE EVENT OCCURRED DURING SETUP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22293554 ↗MalfunctionJun 11, 2025Component Missing; Component Missing
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS MISSING THE COVER AROUND THE LENS. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22183536 ↗MalfunctionMar 25, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21686837 ↗
Other Laparoscope, general & plastic surgery devices
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- 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.
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