VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD OTV-S7H-1DRecalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7H-1D SD CAM HEAD, STRGHT w/ Moire" · 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 the camera that attaches to a laparoscope for surgical video. Its 154 reports mostly describe no image or poor image quality, along with cables splitting and loose connections. The reports include no deaths and no injuries. No recalls name this device. Reports dropped from 10 in the year before to 4 in the latest year.
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
- 154
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 154 adverse event reports that list this exact device (DI 04953170141645), received between Dec 23, 2020 and Aug 11, 2026 — classified as 154 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (74 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/Image74
- Poor Quality Image39
- Loose or Intermittent Connection9
- Material Split, Cut or Torn8
- Connection Problem6
- Erratic or Intermittent Display5
- Gas/Air Leak4
- Leak/Splash4
Patient problems
- No Clinical Signs, Symptoms or Conditions152
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 154 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 11, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209189 ↗MalfunctionJun 10, 2026Material Separation; Material Split, Cut or Torn
THE CUSTOMER REPORTED BLACK SHEATHING ON THE CABLE ITSELF IS COMING APART AND THE INSIDE IS EXPOSED, INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25464530 ↗MalfunctionFeb 27, 2026Output Problem
IT WAS REPORTED THAT THE CAMERA HEAD WAS NO LONGER OPERATING CORRECTLY. THE ISSUE WAS FOUND DURING A REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469483 ↗MalfunctionJan 22, 2026Mechanics Altered
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24151816 ↗MalfunctionSep 18, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NOISY IMAGE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23085695 ↗MalfunctionSep 18, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD PRESENTED A DARK IMAGE. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084712 ↗MalfunctionSep 18, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE CAMERA HEAD HAD LOOSE CABLE. THE ISSUE OCCURRED DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084429 ↗MalfunctionSep 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED SPILT IN THE COATING OF THE CORD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23014777 ↗MalfunctionAug 6, 2025Crack; Crack
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD CRACK ON LENS. THE EVENT HAD OCCURRED DURING SERVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22730978 ↗MalfunctionMay 16, 2025Erratic or Intermittent Display; Gas/Air Leak; Material Split, Cut or Torn; Erratic or Intermittent Display; Gas/Air Leak; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED CABLE FLOODING, CABLE TORSION, IMAGE DEFECTS (NOISE) AND IMAGE CAPTURE FLOODING THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22036598 ↗MalfunctionJan 31, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THAT THE SUBJECT DEVICE CONNECTION TO THE SCOPE IS LOOSE AND FALLING OUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21286829 ↗MalfunctionJan 7, 2025Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21092150 ↗MalfunctionJan 3, 2025Corroded; No Display/Image; Corroded; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE IMAGE IS NOT DISPLAYED AND RUST INSIDE OF CHARGED COUPLED DEVICE AND CABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072081 ↗MalfunctionDec 27, 2024Leak/Splash; Leak/Splash
ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: LAPAROSCOPY PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21030249 ↗MalfunctionOct 21, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD HAD LINES ON THE DISPLAY THAT CAUSED IMAGE INTERFERENCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20495781 ↗MalfunctionOct 18, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE'S IMAGE WAS BLURRED. THE ISSUE OCCURRED AT THE BEGINNING OF A THERAPEUTIC AND DIAGNOSTIC CYSTOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE WITH NO SURGICAL DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20480621 ↗MalfunctionOct 8, 2024Poor Quality Image; Output Problem; Poor Quality Image; Output Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD FALSE CONTACT IN THE CABLE AND THE IMAGE IS COMPLETELY STREAKED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20398243 ↗MalfunctionOct 3, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE IMAGE WAS ABNORMAL, WHEN THE CAMERA HEAD WAS CONNECTING, RED LINES (NOISE) APPEARED IN THE MONITOR IMAGE, SOMETIMES VERTICALLY AND SOMETIMES HORIZONTALLY, AND SOMETIMES DID NOT APPEAR. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20359656 ↗MalfunctionSep 23, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A POOR IMAGE QUALITY. THE ISSUE WAS FOUND DURING REPROCESSING FOR A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE AND THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20278876 ↗MalfunctionSep 18, 2024Corroded; Leak/Splash; Loose or Intermittent Connection; Poor Quality Image; Corroded; Leak/Splash; Loose or Intermittent Connection; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A POOR SCOPE MOUNT CONNECTION, IMAGE NOISE, CORROSION ON THE VIDEO CONNECTOR ELECTRICAL CONTACTS, WATERTIGHTNESS FAILURE IN A SWITCH, AND WATER INTRUSION IN THE IMAGING OF THE MAIN UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20247777 ↗MalfunctionSep 17, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD IT EASY TO BE BLACKOUT AND NEEDED TO BE UNPLUGGED AND RESTARTED WHILE BEING USED WITH A CAMERA ADAPTER AND CAMERA SYSTEM. THE ISSUE WAS FOUND DURING A THERAPEUTIC PROSTATECTOMY PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THE CAMERA ADAPTER AND CAMERA SYSTEM DID NOT MALFUNCTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20237958 ↗MalfunctionSep 16, 2024Disconnection; Poor Quality Image; Disconnection; Poor Quality Image
ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: THE INTENDED PROCEDURE WAS A THERAPEUTIC PROCEDURE, AND IT WAS COMPLETED BY REPLACING OTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20225790 ↗MalfunctionSep 16, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD AN IMAGE PROBLEM BLACKOUT AND NEEDS TO BE UNPLUGGED AND RESTARTED. THE ISSUE OCCURRED DURING PROSTATECTOMY PROCEDURE FOR A THERAPEUTIC TYPE, WHICH WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20224355 ↗MalfunctionSep 4, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT THE CAMERA HEAD HAD POOR CONTACT. THE ISSUE WAS FOUND DURING A HYSTEROSCOPY DIAGNOSTIC EXAMINATION PROCEDURE, THAT WAS COMPLETED WITH A SIMILAR SET OF DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20135181 ↗MalfunctionSep 4, 2024Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THE CAMERA HEAD CABLE CONTACT WAS POOR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20134353 ↗
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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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