CAMERA HEAD MAJ-554Recalls & reported problems
Olympus Medical Systems Corp. · MAJ-554 CAMERA HEAD FOR OTV-SC · Class 2
Quick summary
This Olympus MAJ-554 camera head attaches to a laparoscope to send video from inside the body during surgery. The 62 reports mostly describe the picture dropping out entirely or coming through blurry, noisy, or streaked, with several noticed during cleaning or setup before the patient was involved. No deaths and no injuries are described. There are no recalls naming 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
- 62
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 04953170136931), received between Feb 5, 2021 and Aug 13, 2025 — classified as 62 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (26 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
Most reported problems
Device problems
- No Display/Image26
- Poor Quality Image20
- Image Display Error/Artifact5
- Erratic or Intermittent Display4
- Break2
- Connection Problem2
- Display or Visual Feedback Problem2
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions62
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD POOR IMAGE QUALITY. THE ISSUE WAS FOUND DURING A SETTING UP THE DEVICE BEFORE PATIENT WAS INSIDE THE ROOM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22795272 ↗MalfunctionJul 28, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT DEVICE HAD NO VIDEO IMAGE OUTPUT. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22632591 ↗MalfunctionMay 27, 2025Poor Quality Image; Communication or Transmission Problem; Poor Quality Image; Communication or Transmission Problem
IT WAS REPORTED THAT THE CAMERA HEAD WAS NOT WORKING AND HAD NOISY IMAGE, BUT SUBJECT COULD BE RECOGNIZED. THE EVENT OCCURRED AT SERVICE/MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22093308 ↗MalfunctionMay 7, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD EXPERIENCED A CLARITY ISSUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21978470 ↗MalfunctionApr 25, 2025Break; Break
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907138 ↗MalfunctionFeb 3, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN ABNORMAL IMAGE. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21294333 ↗MalfunctionDec 29, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THE SUBJECT DEVICE HAD NOISY IMAGE (INTERMITTENTLY) AND THE OBJECTS COULD NOT BE RECOGNIZED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032282 ↗MalfunctionDec 6, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN ABNORMAL IMAGE THAT WAS SOMETIMES DISTURBED BY STREAKS. THE EVENT OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20863703 ↗MalfunctionNov 20, 2024Electrical /Electronic Property Problem; Poor Quality Image; Material Split, Cut or Torn; Electrical /Electronic Property Problem; Poor Quality Image; Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED CUT ON CABLE METAL SHEATH, POOR COLOR IMAGE AND FAULTY CHARGE-COUPLED DEVICE (CCD). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20740671 ↗MalfunctionNov 12, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THE CAMERA HEAD HAD A NOISY IMAGE. THE MALFUNCTION WAS IDENTIFIED DURING ROUTINE INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662854 ↗MalfunctionOct 11, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE DISPLAYED AN ABNORMAL IMAGE. THE ISSUE OCCURRED DURING CLEANING AND DISINFECTION FOR A THERAPEUTIC PLASMA CUTTING PROCEDURE WHICH WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20427151 ↗MalfunctionSep 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING ROUTINE INSPECTION THE SUBJECT DEVICE HAD A NOISY AND A FLICKERING IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20300970 ↗MalfunctionSep 24, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE CABLE TWISTING ON THE SUBJECT DEVICE CAUSED THE CAMERA TO FLICKER (TARGET OBJECT WAS RECOGNIZABLE). THE ISSUE WAS FOUND DURING CLEANING AND DISINFECTION. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20290555 ↗MalfunctionSep 23, 2024No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION FROM THE CUSTOMER
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20285459 ↗MalfunctionSep 11, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE CAMERA HEAD HAD NO IMAGE. THE ISSUE WAS FOUND DURING PREPARATION OF A DIAGNOSTIC EAR, NOSE & THROAT PROCEDURE. THE PROCEDURE WAS CANCELLED AND THE ISSUE WAS RESOLVED WITH A SUBSTITUTE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20193362 ↗MalfunctionAug 6, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD NO IMAGE AFTER BEING CONNECTED TO THE 3D LAPAROSCOPE. THIS ISSUE OCCURRED DURING CLEANING AND DISINFECTION FOR A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917726 ↗MalfunctionJul 26, 2024Connection Problem; Connection Problem
IT WAS REPORTED THAT DURING CLEANING AND DISINFECTION, THE SUBJECT DEVICE HAD POOR CONTACT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19841526 ↗MalfunctionJul 25, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO IMAGE WHEN IT TURNED ON. THE ISSUE WAS IDENTIFIED DURING THE REPROCESSING, AND THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19833219 ↗MalfunctionJun 21, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD A POOR QUALITY IMAGE, DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590168 ↗MalfunctionApr 26, 2024Disconnection; Leak/Splash; Disconnection; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED A DISCONNECTION AND CABLE FLOODING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19191901 ↗MalfunctionApr 10, 2024Poor Quality Image; Connection Problem; Poor Quality Image; Connection Problem
IT WAS REPORTED THAT THE CAMERA HEAD HAD AN IMAGE ABNORMALITY ISSUE WITH FLASHING SCREEN AND RED OR PAN RED IMAGE. THE CABLE HAD POOR CONTACT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19080706 ↗MalfunctionApr 3, 2024Leak/Splash; Leak/Splash
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE CAMERA CABLE WAS FLOODED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19031828 ↗MalfunctionFeb 21, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD DISPLAYED A NOISY AND FLICKERING IMAGE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN EAR, NOSE, AND THROAT ENDOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED A DIFFERENT VIDEO SYSTEM CENTER AND SCOPE WITH NO SURGICAL DELAY. THE CONCOMITANT DEVICES WERE WORKING AS INTENDED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18751208 ↗MalfunctionJan 29, 2024Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED THE CABLE HEAD WAS DAMAGED, CAUSING INTERFERENCE WHEN MOVING IT. THE ISSUE OCCURRED FOLLOWING THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18596864 ↗MalfunctionDec 6, 2023No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
THE CUSTOMER REPORTED TO OLYMPUS THAT THE CAMERA HEAD IMAGE WOULD NOT APPEAR. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18276257 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.