EVIS EXERA SIGMOIDOVIDEOSCOPE OLYMPUS CF TYPE Q160S (UDI 04953170339134)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 04953170339134), received between Apr 19, 2024 and Jul 29, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “No Display/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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065964 ↗
• MalfunctionJul 28, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057091 ↗
• MalfunctionJul 27, 2026Erratic or Intermittent Display

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50043270 ↗
• MalfunctionJun 12, 2026Residue After Decontamination

  THE CUSTOMER RETURNED THE SIGMOIDOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE TECHNICIAN IDENTIFIED THE DEVICE HAD DARK DEBRIS IN LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25488451 ↗
• MalfunctionMay 12, 2026Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL IN AIR-WATER CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25148039 ↗
• MalfunctionJan 28, 2026Contamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD BLACK FOREIGN MATERIAL IN THE AIR/WATER NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24204562 ↗
• MalfunctionJan 28, 2026No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203489 ↗
• MalfunctionJan 2, 2026Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED WHITE RESIDUE IN THE COVER GLASS AND LIGHT GUIDE ROD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946278 ↗
• MalfunctionDec 26, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED INTERMITTENT IMAGE AND NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896761 ↗
• MalfunctionDec 22, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD NO IMAGE WITH BLACK SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863688 ↗
• MalfunctionDec 17, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED NO IMAGE, A BLACK SCREEN, AND HORIZONTAL LINES ON THE SCREEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828276 ↗
• MalfunctionNov 25, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE SUBJECT DEVICE HAD AN ERROR CODE MALFUNCTION (B30). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653374 ↗
• MalfunctionNov 25, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED A LOSS OF IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644343 ↗
• MalfunctionNov 20, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS OBSERVED THAT DURING EVALUATION, THE SIGMOIDOVIDEOSCOPE EXHIBITED A DARK RESIDUE ON THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612890 ↗
• MalfunctionNov 10, 2025No Display/Image; No Display/Image

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511440 ↗
• MalfunctionNov 5, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THE SIGMOIDOVIDEOSCOPE EXPERIENCED A PROBLEM OF BEING UNABLE TO VIEW SCREEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23476859 ↗
• MalfunctionSep 25, 2024Device Reprocessing Problem; Improper or Incorrect Procedure or Method; Device Reprocessing Problem; Improper or Incorrect Procedure or Method

  OLYMPUS WAS INFORMED THAT, DURING AN ONSITE VISIT, THE USER FACILITY STAFF WAS NOT SUCTIONING ANY OF THEIR SCOPES DUE TO LACK OF A SUCTIONING SOURCE. THEY HAVE NOT BEEN REPROCESSING ACCESSORIES SUCH AS THE INJECTION TUBING OR SUCTION CLEANING ADAPTER. THEY HAVE BEEN DEVIATING FROM INSTRUCTIONS FOR USE BY NOT PERFORMING THE STEPS CORRECTLY. FLUSHING WAS BEING PERFORMED WITH A SYRINGE RATHER THAN INJECTION TUBING, THEY HAVE NOT FOLLOWED DELAYED REPROCESSING, AND AT TIMES WERE REPROCESSING THE SCOPES THE FOLLOWING DAY AFTER A PROCEDURE. NO PATIENT INFECTIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20299667 ↗
• MalfunctionJul 15, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THE SIGMOIDOVIDEOSCOPE HAD INTERNAL DEFECTS OF CHANNEL BLOCKED WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19745423 ↗
• MalfunctionApr 19, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THAT THE GI SCOPE HAD A CLOGGED NOZZLE WITH BLACK DEBRIS INSIDE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19149211 ↗