CAMERA HEAD OTV-S7H-1D-L08ERecalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of CAMERA HEAD (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus laparoscope camera head is the video unit used with a laparoscope in surgery. Its 182 reports include no deaths and no injuries. Many describe no image or poor image quality, and some describe water leaking in, corrosion or torn cables. No recalls name this device, and there are no reports in the last 12 months, compared with 6 in the prior 12 months.
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
- 182
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 182 adverse event reports that list this exact device (DI 04953170323584), received between Jan 7, 2021 and Feb 5, 2025 — classified as 182 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (86 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/Image86
- Poor Quality Image37
- Leak/Splash12
- Corroded9
- Crack9
- Material Split, Cut or Torn9
- Disconnection8
- Break6
Patient problems
- No Clinical Signs, Symptoms or Conditions179
- No Consequences Or Impact To Patient2
- Insufficient Information1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 182 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD ABNORMAL IMAGE. THE ISSUE OCCURRED DURING OUT OF THE BOX FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21314658 ↗MalfunctionJan 21, 2025Leak/Splash; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A FAILED LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21200356 ↗MalfunctionJan 13, 2025Gas/Air Leak; Gas/Air Leak
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE SCOPE MOUNT AND THE IMAGING SYSTEM OF THE SUBJECTED DEVICE WERE FLOODED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21146392 ↗MalfunctionJan 7, 2025Corroded; Leak/Splash; Material Deformation; Corroded; Leak/Splash; Material Deformation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED WATER TIGHTNESS IS LOST, ELECTRICAL CONTACT WAS CORRODED AND CABLE HAD DEFORMATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093076 ↗MalfunctionJan 7, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECTED DEVICE EXHIBITED A NOISY IMAGE. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21093000 ↗MalfunctionNov 8, 2024Break; No Display/Image; Mechanical Problem; Break; No Display/Image; Mechanical Problem
IT WAS REPORTED THAT THE IMAGE ON THE SUBJECT DEVICE DID NOT DISPLAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20642707 ↗MalfunctionOct 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE RUBBER LINING OF THE CAMERA HEAD'S CABLE HAD BEEN RIPPED OFF WHICH WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470416 ↗MalfunctionSep 19, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CAMERA HEAD DID NOT DISPLAY THE IMAGE. THE PROBLEM WAS FOUND DURING EQUIPMENT INSPECTION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20263390 ↗MalfunctionSep 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED FOR CAMERA HEAD THE IMAGE WAS BLACK. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20191609 ↗MalfunctionSep 10, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE SUBJECT DEVICE'S CABLE MATERIAL WAS DISINTEGRATED. THE ISSUE WAS IDENTIFIED DURING PREPARATION FOR USE FOR AN UNKNOWN DIAGNOSTIC PROCEDURE. THERE WAS NO SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO OTHER DEVICES WERE CONNECTED TO THE SUBJECT DEVICE WHEN THE FAILURE OCCURRED, AND NO ERROR MESSAGES WERE OBSERVED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20180407 ↗MalfunctionAug 28, 2024Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED UNIT FAILED LEAK TEST AND A PUNCTURE ON CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20085488 ↗MalfunctionAug 23, 2024Disconnection; No Display/Image; Disconnection; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD CORD DISCONNECTION AND DID NOT DISPLAY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20055399 ↗MalfunctionAug 22, 2024Disconnection; Disconnection
IT WAS REPORTED THAT THE CAMERA HEAD HAD CORD DISCONNECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20042162 ↗MalfunctionAug 22, 2024Crack; Crack
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A CRACK WHERE THEY PLUG IT IN. THE EVENT OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20040883 ↗MalfunctionAug 9, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE HAD A BLURRY IMAGE. THE ISSUE WAS IDENTIFIED DURING PREPARATION OF USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19952064 ↗MalfunctionAug 8, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT WHEN PLUGGED INTO THE CAMERA HEAD, THE SCOPE WAS DIM DESPITE WHITE BALANCING AND THE IMAGE WAS TOO DARK. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19939899 ↗MalfunctionAug 8, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NOISE WHEN USING THE ELECTRIC KNIFE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19939700 ↗MalfunctionJul 19, 2024Corroded; Fracture; Leak/Splash; Gas/Air Leak; Material Split, Cut or Torn; Corroded; Fracture; Leak/Splash; Gas/Air Leak; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE FOLLOWING ISSUES: THE CAMERA CABLE WAS BROKEN (BURN), THERE WAS AN AIR LEAK IN THE CAMERA CABLE, WATER IMMERSION IN THE MAIN UNIT IMAGING, AS WELL IN THE CAMERA CABLE, THE MAIN UNIT WAS FLOODED, THE SCOPE MOUNT AND THE FREE LOCK LEVER WERE CORRODED, AND THERE WAS A SCRATCH ON THE LENS OF THE MAIN BODY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19780510 ↗MalfunctionJul 18, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE DISPLAYED A COMPLETELY DARK IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19774121 ↗MalfunctionJul 17, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD IMAGE RUSTLING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19765255 ↗MalfunctionJul 16, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE SUBJECT DEVICE CABLE COATING WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19749594 ↗MalfunctionJul 15, 2024Corroded; Crack; Loose or Intermittent Connection; Poor Quality Image; Material Integrity Problem; Corroded; Crack; Loose or Intermittent Connection; Poor Quality Image; Material Integrity Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED CONNECTOR CRACKS, ELECTRICAL CONTACT CORROSION, FREE LOCK LEVER CORROSION, AND SCOPE MOUNT CORROSION, FILM RUPTURE, AND IMAGING DETERIORATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19742552 ↗MalfunctionJul 9, 2024Gas/Air Leak; Gas/Air Leak
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FLOODING DUE TO CABLE SCRATCHES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19702562 ↗MalfunctionJul 9, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CAMERA HEAD SUDDENLY STOPPED DISPLAYING IMAGES ON THE MONITOR AND BECAME UNUSABLE DURING AN UNSPECIFIED TYPE OF PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19700730 ↗MalfunctionJul 3, 2024Disconnection; Disconnection
IT WAS REPORTED THAT IN THE MIDDLE OF AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE CAMERA HEAD PRESENTED A DISCONNECTION. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19668482 ↗
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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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