AUTOCLAVABLE CAMERA HEAD OTV-S7H-1NA-12ERecalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7H-1NA-12E,VISERA AUTOCLA VABLE CAM" · Class 2
All models of AUTOCLAVABLE CAMERA HEAD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus autoclavable camera head is the sterilizable camera used on the endoscope tower for laparoscopy and other surgical scopes. The 53 reports mostly describe the camera losing its image entirely, showing a poor or distorted picture, or failing to focus, along with some cracked or broken parts and cable faults; none describe patient harm. There are 53 malfunctions, no deaths and no injuries, and 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
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 04953170141898), received between Nov 13, 2020 and May 7, 2026 — classified as 53 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (20 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/Image20
- Poor Quality Image17
- Break3
- Material Split, Cut or Torn3
- Display or Visual Feedback Problem2
- Contamination /Decontamination Problem1
- Disconnection1
- Erratic or Intermittent Display1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Leak/Splash; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED ABNORMALITY IN THE IMAGE, NORMAL OBSERVATION WAS NOT POSSIBLE AND FAILED THE AIR LEAKAGE TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113550 ↗MalfunctionFeb 6, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
IT WAS REPORTED THAT THE CAMERA HEAD CABLE HAD A SHORT IT IN AND WAS NOT WORKING PROPERLY. THE EVENT OCCURRED DURING A DIAGNOSTIC HYSTEROSCOPY PROCEDURE, AND IT WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21328603 ↗MalfunctionDec 23, 2024Display or Visual Feedback Problem; Image Orientation Incorrect; Display or Visual Feedback Problem; Image Orientation Incorrect
IT WAS REPORTED THE CAMERA HEAD IMAGE WAS DISPLACED AND THE REST WAS BLACK. THE ISSUE OCCURRED AFTER A DIAGNOSTIC UTERINE ENDOSCOPY PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21009367 ↗MalfunctionDec 11, 2024Misfocusing; Misfocusing
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED THE UNABLE TO FOCUS. THERE WERE O REPORTS PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20904256 ↗MalfunctionDec 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20839326 ↗MalfunctionNov 20, 2024Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737732 ↗MalfunctionOct 15, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE SUBJECT DEVICE HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20457244 ↗MalfunctionOct 9, 2024Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE WAS BROKEN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20410635 ↗MalfunctionSep 30, 2024Disconnection; Disconnection
IT WAS REPORTED THE CORD OF THE SUBJECT DEVICE DISCONNECTED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20334036 ↗MalfunctionSep 23, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE'S CAMERA DROWNED FOLLOWING SERVICE FLOODING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20287887 ↗MalfunctionSep 12, 2024No Device Output; No Device Output
IT WAS REPORTED THE CAMERA HEAD WAS NOT FUNCTIONING. THE EVENT OCCURRED DURING PREPARATION FOR AN UNSPECIFIED PROCEDURE. THERE WAS A 10 MINUTE DELAY BUT THE PROCEDURE WAS COMPLETED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20207248 ↗MalfunctionSep 11, 2024Loose or Intermittent Connection; Poor Quality Image; Loose or Intermittent Connection; Poor Quality Image
IT WAS REPORTED THE CAMERA HAD A LOOSE CONNECTION AND WAS PRODUCING A YELLOW IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20197200 ↗MalfunctionAug 9, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS OBSERVED, THAT DURING THE DEVICE EVALUATION. THE CAMERA HEAD EXHIBITED A LOSS OF WATERTIGHTNESS ON THE CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19949303 ↗MalfunctionJul 26, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE CAMERA HEAD HAD A NOISY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19839485 ↗MalfunctionJul 19, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD AN IMAGE THAT WAS DISTORTED AND GRAINY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19780468 ↗MalfunctionJul 10, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A VERY BAD VISION OR VERY POOR VISIBILITY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19716305 ↗MalfunctionJul 10, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD POOR IMAGE QUALITY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19712096 ↗MalfunctionJul 5, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT THE CAMERA HEAD DID NOT WORK. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19680721 ↗MalfunctionJun 11, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD A SMALL IMAGE INTERRUPTIONS AND COLORS ON THE SCREEN INSTEAD OF THE IMAGE. THE THERAPEUTIC URETEROSCOPY WAS COMPLETED WITH THE SAME SET OF EQUIPMENT WITHOUT A DELAY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19513072 ↗MalfunctionJun 10, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, DURING PREPARATION FOR USE FOR A THERAPEUTIC LAPAROSCOPIC SURGERY THE CAMERA HEAD HAD ABNORMAL IMAGE. 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 19505958 ↗MalfunctionApr 25, 2024No Display/Image; No Display/Image
IT WAS REPORTED, THE CAMERA HEAD'S PLUG-IN PORTION WAS NOT SECURE. AND WHEN IT WAS MOVED, THE VIDEO IMAGE IS EFFECTED. THE ISSUE OCCURRED, DURING PREPARATION OF A THERAPEUTIC LAPAROSCOPIC HERNIA REPAIR. AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. A REQUEST FOR FURTHER CLARIFICATION OF THE "VIDEO IMAGE EFFECTED" IS IN PROGRESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181264 ↗MalfunctionApr 19, 2024Break; Gas/Air Leak; Break; Gas/Air Leak
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED CABLE FLOODING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19141916 ↗MalfunctionApr 5, 2024Poor Quality Image; Poor Quality Image
THIS SUPPLEMENTAL IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURERS FINAL INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19050823 ↗MalfunctionMar 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE CAMERA HEAD'S CORD HAD A CUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19000338 ↗MalfunctionMar 21, 2024Break; Break
IT WAS REPORTED, THE SUBJECT DEVICE CABLE WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18951575 ↗
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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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