AUTOCLAVABLE CAMERA HEAD OTV-S7H-NA-12ERecalls & reported problems
Olympus Medical Systems Corp. · "OTV-S7H-NA-12E,VISERA AUTOCLA VABLE CAME" · 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 reusable video camera attached to a surgical scope. The 52 reports mostly describe image problems — blank or black screens, blurry or distorted pictures, and horizontal stripes — plus loose or intermittent connections to the scope mount, and a couple of reports of parts breaking or corroding. Most issues were found during pre-use checks or reprocessing, with no patient involvement, and no deaths or injuries were reported. 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
- 52
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 04953170141867), received between Nov 9, 2020 and Jun 7, 2026 — classified as 52 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (23 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/Image23
- Poor Quality Image22
- Loose or Intermittent Connection7
- Erratic or Intermittent Display2
- Activation Problem1
- Break1
- Corroded1
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 7, 2026Loose or Intermittent Connection; Activation Problem
THE CUSTOMER REPORTED THAT CAMERA IS TAKING PICTURES WITHOUT PUSHING ANY BUTTONS AND NOT CONNECTING PROPERLY DURING A SET UP PROCEDURE INVOLVING AN OLYMPUS CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25422536 ↗MalfunctionAug 5, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DISTORTED IMAGE DUE TO FAULTY CHARGED COUPLE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22720145 ↗MalfunctionMar 10, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21564394 ↗MalfunctionDec 26, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE CAMERA HEAD EXHIBITED A BLACK SCREEN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21019271 ↗MalfunctionOct 30, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED DURING PRE-USE INSPECTION THAT THE SUBJECT DEVICE HAD HORIZONTAL STRIPE IN THE IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570722 ↗MalfunctionSep 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD BLURRY BLUE SCREEN. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20301009 ↗MalfunctionAug 22, 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 20031102 ↗MalfunctionAug 6, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS OBSERVED, DURING THE DEVICE EVALUATION. THAT THE SCOPE MOUNT OF THE SUBJECT DEVICE WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19918650 ↗MalfunctionJul 22, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD NO IMAGE. THE EVENT WAS IDENTIFIED DURING PREPARATION AND PRIOR TO SEDATION FOR A ENDOSCOPIC VEIN HARVEST PROCEDURE IN CONJUNCTION WITH CORONARY ARTERY BYPASS GRAFTING. 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 19795212 ↗MalfunctionJul 9, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE SUBJECT DEVICE HAD A POOR IMAGE QUALITY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19704260 ↗MalfunctionJul 9, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A PICTURE THAT WAS NOT CLEAR. THE ISSUE WAS FOUND DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19701217 ↗MalfunctionJul 8, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING PREPARATION FOR USE FOR AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE SUBJECT DEVICE HAD A POOR IMAGE QUALITY. 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 19693059 ↗MalfunctionJul 3, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THE CAMERA HEAD HAD POOR IMAGE QUALITY. THE ISSUE WAS FOUND DURING PREPARATION FOR A THERAPEUTIC PROCEDURE THAT WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19668295 ↗MalfunctionJun 27, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD HAD FAULTY IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19630358 ↗MalfunctionJun 27, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED, THAT THE SUBJECT DEVICE HAD POOR VIDEO IMAGE QUALITY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19623576 ↗MalfunctionMay 23, 2024Leak/Splash; Leak/Splash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD CABLE FAILED THE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382835 ↗MalfunctionMay 23, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE CAMERA HEAD HAD A NOISY IMAGE. THE EVENT OCCURRED DURING AT THE BEGINNING OF AN UNSPECIFIED THERAPEUTIC PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19381269 ↗MalfunctionMay 16, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THE CAMERA HEAD'S COUPLER SECTION WAS LOOSENED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19337174 ↗MalfunctionApr 11, 2024Loose or Intermittent Connection; Poor Quality Image; Loose or Intermittent Connection; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD COUPLER WAS LOOSE. THE ISSUE WAS FOUND AT PREPARATION FOR USE FOR A THERAPEUTIC LAPAROSCOPIC SURGERY. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WAS NO PATIENT IMPACT, NO HARM REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19092843 ↗MalfunctionMar 29, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE CAMERA HEAD WAS DEFECTIVE AND HAD A BLACK IMAGE. THE REPORTED MALFUNCTION OCCURRED DURING PREPARATION FOR A THERAPEUTIC GYNECOLOGY PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19005659 ↗MalfunctionMar 14, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE CAMERA HEAD HAD AN IMAGE DISTORTION . NO PATIENT HARM OR INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18906220 ↗MalfunctionMar 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED THE SUBJECT DEVICE HAD A LOOSE CONTACT. THE REPORTED INCIDENT OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WAS NO DELAY IN PROCEDURE AND NO PATIENT HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18896535 ↗MalfunctionMar 8, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE PRESENTED NO IMAGE. ADDITIONAL INFORMATION REGARDING THE VENT WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865082 ↗MalfunctionMar 7, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECT DEVICE PRESENTED NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18854349 ↗MalfunctionFeb 20, 2024Crack; Crack
IT WAS REPORTED "THERE WAS AN ELECTRICAL CRACK IN THE UNIVERSAL CORD" OF THE SUBJECT DEVICE. THE ISSUE HAPPENED DURING REPROCESSING PRIOR TO AN UNSPECIFIED PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT, NO HARM REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18741708 ↗
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page