HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12QRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04953170228865), received between Feb 8, 2021 and Dec 6, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (14 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.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2024Poor Quality Image; Material Split, Cut or Torn; Poor Quality Image; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUBJECT DEVICE CABLE WAS ALSO DAMAGED AND IN CERTAIN POSITION OF THE CABLE WHITE LINES APPEAR ACROSS THE IMAGE. THE ISSUE WAS OBSERVED DURING SEDATION OF AN UNKNOWN PROCEDURE AND THE DEVICE WAS PRESENT INSIDE OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863789 ↗
• MalfunctionJul 10, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC GASTROSCOPY THAT WAS ABLE TO BE COMPLETED USING THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710467 ↗
• MalfunctionMay 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19262648 ↗
• MalfunctionMar 22, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE CAMERA HEAD HAD FLEETING LINES IN THE IMAGE THAT APPEARED WHEN THE SHAVER WAS RUNNING DURING SHOULDER ARTHROSCOPY. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE (SHOULDER ARTHROSCOPY). THE PROCEDURE WAS COMPLETED USING THE SAME EQUIPMENT. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963844 ↗
• MalfunctionMar 19, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED, THE CAMERA CORD WAS NOT WORKING. THE DEVICE WAS NOT STAYING CONNECTED AND THE PORT WAS LOOSE. THE ISSUE OCCURRED AT THE BEGINNING OF A SHOULDER ARTHROSCOPY PROCEDURE AND WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933970 ↗
• MalfunctionSep 7, 2023No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT DURING INITIAL INSPECTION OF THE HD AUTOCLAVABLE CAMERA HEAD, THERE WAS EVIDENCE OF IMAGE PROBLEM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED: BLACK SCREEN, NO CAMERA IMAGE AND COMMUNICATION ERROR. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697505 ↗
• MalfunctionJul 26, 2023No Display/Image; No Display/Image

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, FOR A HD AUTOCLAVABLE CAMERA HEAD, EXHIBITING IMAGE NOISE. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE CAMERA HEAD EXHIBITED NO IMAGE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17395778 ↗
• MalfunctionJul 10, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE HD AUTOCLAVABLE CAMERA HEAD HAD WHITE LINES AND A FUZZY PICTURE. THE ISSUE OCCURRED DURING DIAGNOSTIC PROCEDURE WITH A TWO-MINUTE DELAY. THE PATIENT WAS NOT IMPACTED BY THE MALFUNCTION, NOR DID IT AFFECT THE OUTCOME OF THE DIAGNOSTIC PROCEDURE. NO MEDICAL INTERVENTION WAS NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295057 ↗
• MalfunctionMay 24, 2023Electrical /Electronic Property Problem; Poor Quality Image; Electrical /Electronic Property Problem; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE HD AUTOCLAVABLE CAMERA HEAD WAS PRODUCING IMAGE WITH STRIPS AND THE COLOR CHANGED. INSPECTION AND TESTING OF DEVICE FOUND FLICKERING IMAGE WAS BEING PRODUCED DUE TO A FAULTY CABLE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16998991 ↗
• MalfunctionFeb 25, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT NOISE GENERATED WHEN TOUCHING THE BASE OF THE CONNECTOR OR HEAD WHILE USING HD AUTOCLAVABLE CAMERA HEAD. THE ISSUE OCCURRED DURING PREPARATION FOR USE, AND THE THERAPEUTIC PROCEDURE (ENDOSCOPIC SINUS SURGERY) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440914 ↗
• MalfunctionFeb 17, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT, DURING REPROCESSING, THERE WAS NO IMAGE FROM THE SUBJECT DEVICE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400293 ↗
• MalfunctionOct 14, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, DURING PREPARATION, THE HD AUTOCLAVABLE CAMERA HEAD HAD NO IMAGE. IT WAS NOTED THAT NO PROCEDURE WAS AFFECTED BY THIS EVENT AS IT OCCURRED OUTSIDE FROM THE PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610696 ↗
• MalfunctionAug 10, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THE HD AUTOCLAVABLE CAMERA HEAD IS UNABLE TO DISPLAY IMAGE. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199498 ↗
• MalfunctionMay 23, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THE HD AUTOCLAVABLE CAMERA HEAD DISPLAY BLACK IMAGE. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14480314 ↗
• MalfunctionMar 17, 2022No Display/Image; No Display/Image

  OLYMPUS CUSTOMER CARE WAS INFORMED THAT THE CUSTOMER HIGH DEFINITION AUTOCLAVABLE CAMERA HEAD WILL BE RETURNED FOR A REPORTED ¿BLACK SCREEN WITH NO IMAGE¿ FOUND DURING PREPARATION FOR USE. NO PATIENT INJURY OR HARM WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13796003 ↗
• MalfunctionFeb 14, 2022No Display/Image; No Display/Image

  THE CUSTOMER CONTACTED OLYMPUS TO REPORT THE HD AUTOCLAVABLE CAMERA HEAD WOULD NOT TAKE PICTURES. THIS EVENT OCCURRED DURING A THERAPEUTIC PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529497 ↗
• MalfunctionFeb 10, 2022Poor Quality Image; Poor Quality Image

  A USER FACILITY REPORTED TO OLYMPUS THAT, THE HD AUTOCLAVABLE CAMERA HEAD HAD AN IMAGE ISSUE. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE IMAGE WAS DARK DUE TO A DEFECTIVE CHARGED COUPLED DEVICE. THIS REPORT IS BEING SUBMITTED FOR THE EVENT FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508253 ↗
• MalfunctionAug 17, 2021No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THAT DURING SET-UP THE UNIT DISPLAYED A BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT. THE UNIT WAS RETURNED FOR EVALUATION AND FOUND NO IMAGE WAS DISPLAYED DUE TO FAULTY CHARGE-COUPLED DEVICE (CCD) WHICH IS CONSIDERED TO BE A REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333658 ↗
• MalfunctionJul 27, 2021No Display/Image; No Display/Image

  AS REPORTED FOR THIS EVENT BY THE CUSTOMER, A TEAR IN THE CORD INSULATION WAS OBSERVED. THERE IS NO HARM REPORTED TO ANY PATIENT. THE DEVICE WAS SENT IN FOR REPAIR. DURING ESTIMATION, IT WAS NOTED THAT THE DEVICE YIELDED NO IMAGE DUE TO A FAULTY CHARGE COUPLE DEVICE (CCD) UNIT. THIS MEDWATCH IS BEING SUBMITTED FOR THE ISSUE OF NO IMAGE DUE TO A FAULTY CHARGE COUPLE DEVICE (CCD) UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231597 ↗
• MalfunctionMay 27, 2021No Display/Image; No Display/Image

  THE HIGH DEFINITION AUTOCLAVABLE CAMERA HEAD DISPLAYED INTERMITTENT NOISE/ WHITE STREAKS IN THE IMAGE. NO PATIENT HARM OR INJURY OCCURRED DUE TO THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892985 ↗
• MalfunctionMar 8, 2021No Display/Image; No Display/Image

  DURING PREPARATION FOR USE THE DEVICE WAS FOUND WITH NO IMAGE. THE CAMERA WHEN PLUGGED IN WOULD NOT GET AN IMAGE. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11440180 ↗
• MalfunctionFeb 10, 2021No Display/Image; Material Twisted/Bent; Material Split, Cut or Torn; No Display/Image; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING PREPARATION FOR USE FOR A DIAGNOSTIC PROCEDURE, THE USER COULD NOT GET AN IMAGE WITH THE HD AUTOCLAVABLE CAMERA HEAD. THE CUSTOMER REPORTED NO OTHER DEVICES WERE INVOLVED AND THERE WAS NO DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. AS REPORTED, THERE WAS NO CONSEQUENCE OR IMPACT TO THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11307452 ↗
• MalfunctionFeb 8, 2021No Display/Image; No Display/Image

  A USER FACILITY REPORTED THAT WHEN PLUGGING THE CAMERA UNIT IN, THERE IS NO PICTURE ON A CAMERA HEAD. THERE WAS NO PATIENT INVOLVEMENT OR INJURIES REPORTED. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11297130 ↗