AUTOCLAVABLE CAMERA HEAD OTV-S7H-NA-10ERecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04953170141805), received between May 19, 2022 and May 15, 2026 — classified as 26 malfunctions.

The most frequently reported specific device problem is “Poor Quality Image” (9 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Poor Quality Image

  THE CAMERA HEAD WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A PUNCTURE IN THE CORD. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, LINES SHOWING ON THE IMAGE DUE TO FAULTY CHARGE COUPLED DEVICE (CCD) WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25191877 ↗
• MalfunctionDec 10, 2025Material Separation; Material Separation

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768855 ↗
• MalfunctionMay 27, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A NICK IN THE CORD. THE ISSUE OCCURRED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087788 ↗
• MalfunctionNov 26, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT, THE SUBJECT DEVICE EXHIBITED POOR IMAGE. THE ISSUE WAS OBSERVED DURING SET UP BEFORE THE PATIENT WAS IN ROOM. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20778500 ↗
• MalfunctionOct 28, 2024Poor Quality Image; Optical Discoloration; Poor Quality Image; Optical Discoloration

  IT WAS REPORTED THE AUTOCLAVABLE CAMERA HEAD HAD STARTED WORKING BAD. THE IMAGE BECAME BLURRY AND TURNED GREEN. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551253 ↗
• MalfunctionOct 9, 2024Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED WATER INGRESS INTO THE IMAGING DEVICE, WATER INGRESS INTO THE CABLE, AND MAIN BODY CRACKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20411914 ↗
• MalfunctionSep 4, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT, THE SUBJECT DEVICE HAD A DARK IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136479 ↗
• MalfunctionJul 29, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT SOMETIMES THERE WAS VIDEO IMAGE DISTORTION OF THE SUBJECT DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19850151 ↗
• MalfunctionJul 15, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED, THAT THE SUBJECT DEVICE DISPLAYED POOR IMAGE QUALITY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742739 ↗
• MalfunctionJul 5, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THE SUBJECT DEVICE HAD AN AXIS MISALIGNMENT WITH THE RING ROTATED AROUND. THE ISSUE OCCURRED DURING PRE-USED INSPECTION. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19680348 ↗
• MalfunctionJun 6, 2024Corroded; Leak/Splash; Corroded; Leak/Splash

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CAMERA HEAD EXHIBITED CABLE AND IMAGE FLOODING AND SCOPE MOUNT CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19480434 ↗
• MalfunctionMay 13, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED, THE CAMERA HEAD HAD A NOISE IMAGE DEFECT. THE ISSUE OCCURRED AT INSPECTION BEFORE USE OF A THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296658 ↗
• MalfunctionApr 2, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED, THERE WAS POOR IMAGE QUALITY WITH THE CAMERA HEAD. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19027801 ↗
• MalfunctionMar 12, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE'S COUPLER WAS FOUND TO BE LOOSE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888088 ↗
• MalfunctionMar 11, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE SUBJECT DEVICE HAD WATER INVASION FROM FOCUS RING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18874246 ↗
• MalfunctionJan 2, 2024Loose or Intermittent Connection; Poor Quality Image; Loose or Intermittent Connection; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE AUTOCLAVABLE CAMERA HEAD HAD POOR CONTACT AND IMAGE WAS BLURRY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18431474 ↗
• MalfunctionOct 24, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT BEFORE AN UNSPECIFIED PROCEDURE DURING PREPARATION FOR USE, THE AUTOCLAVABLE CAMERA HEAD HAD NO IMAGE. THE DEVICE WAS INSPECTED BEFORE USE. THERE WAS NO PATIENT HARM REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000332 ↗
• MalfunctionJun 9, 2023Output Problem; Output Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE AUTOCLAVABLE CAMERA HEAD WAS UNABLE TO WHITE BALANCE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099744 ↗
• MalfunctionJun 7, 2023Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER REPORTED THE OLYMPUS AUTOCLAVABLE CAMERA HEAD CAUSED THE DISPLAYED IMAGE TO PARTIALLY DISAPPEAR. THE ISSUE WAS IDENTIFIED DURING REPROCESSING. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17083939 ↗
• MalfunctionFeb 23, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE USING THE AUTOCLAVABLE CAMERA HEAD, THE CUSTOMER OBSERVED COMPLETELY DEAD / DARK IMAGE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429528 ↗
• MalfunctionDec 27, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THERE WAS AN IMAGE PROBLEM WHILE USING THE AUTOCLAVABLE CAMERA HEAD. THE ISSUE OCCURRED DURING THE PROCEDURE AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050906 ↗
• MalfunctionNov 9, 2022No Display/Image; No Display/Image

  THE ISSUE OCCURRED DURING PREPARATION FOR USE (FUNCTION CHECK). THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO OTHER DEVICES REPLACED OR INVOLVED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760479 ↗
• MalfunctionAug 16, 2022No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THERE WAS NO IMAGE FROM THE SUBJECT DEVICE. THERE WAS NO EFFECT ON A PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15237428 ↗
• MalfunctionJun 27, 2022Connection Problem; Connection Problem

  OLYMPUS (OMSC) WAS INFORMED THAT THE CUSTOMER AUTOCLAVABLE CAMERA HEAD WAS RETURNED TO OLYMPUS FOR REPAIR FOR A REPORTED ¿DISCONNECTION OF THE CONNECTOR CONNECTION¿. THE REPORTED PROBLEM WAS FOUND DURING AN UNSPECIFIED EVENT. NO DEATH, INJURY OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14836949 ↗
• MalfunctionMay 24, 2022No Display/Image; No Display/Image

  OLYMPUS WAS INFORMED VIA SERVICE INQUIRY THAT THE CUSTOMER AUTOCLAVABLE CAMERA HEAD HAD A NO IMAGE MALFUNCTION, THE IMAGE IS BLACK. THE EVENT WAS FOUND DURING AN UNSPECIFIED EVENT. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14483667 ↗