EVIS EXERA SIGMOIDOVIDEOSCOPE OLYMPUS CF TYPE Q160S (UDI 04953170067310)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170067310), received between Jun 18, 2021 and Jun 8, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Corroded

  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 CORROSION ON NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25432763 ↗
• MalfunctionApr 8, 2026Corroded; Residue After Decontamination

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD FOREIGN MATERIAL PRESENT IN THE NOZZLE AND EXHIBITED NOZZLE CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24818476 ↗
• MalfunctionApr 1, 2026Corroded

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756570 ↗
• MalfunctionMar 17, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SIGMOIDOVIDEOSCOPE HAD A FOREIGN MATER AT THE AIR WATER CHANNEL AND TUBE OF THE CONTROL UNIT AND AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615178 ↗
• MalfunctionFeb 17, 2026Failure to Clean Adequately

  IT WAS REPORTED THAT THE SIGMOIDOVIDEOSCOPE HAD LEAKAGE OF BLACK LIQUID. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369995 ↗
• MalfunctionJan 28, 2026Poor Quality Image

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24204301 ↗
• MalfunctionOct 3, 2024Device Reprocessing Problem; Device Reprocessing Problem

  OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, CONCERNS WERE MENTIONED TO THE ENDOSCOPY SUPPORT SPECIALIST IN REGARDS TO REPROCESSING ENDOSCOPES. USER FACILITY STAFF MENTIONED THAT THEY ARE NOT ABLE TO BEGIN THE PRE-CLEANING PHASE DUE TO PATIENTS RECOVERING IN THE PROCEDURE ROOM. STAFF ALSO VOICED CONCERNS ABOUT SCOPES BEING HUNG FOR DAYS IN THE PROCEDURE ROOM AND NOT PROPERLY STORED AFTER HIGH-LEVEL DISINFECTION. NO PATIENT INFECTIONS OR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358864 ↗
• MalfunctionDec 20, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THEY NEVER USED THE SIGMOIDOVIDEOSCOPE SINCE THEY RECEIVED IT BACK FROM REPAIRED AND THE AIR CHANNEL WAS BLOCKED. THE ISSUE WAS FOUND AT REPROCESSING. DURING EVALUATION, THE FOLLOWING REPORTABLE ISSUE FOUND THAT THE NOZZLE WAS CLOGGED. THERE WERE NO REPORTS OF PATIENT OR USER HARM. THIS MDR IS BEING SUBMITTED TO CAPTURE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18364859 ↗
• MalfunctionNov 15, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THE EVIS EXERA SIGMOIDOVIDEOSCOPE HAD NO AIR/WATER FLOW, A BLOCKED AIR CHANNEL, AND THE NOZZLE WAS CLOGGED. A BLOCKED AIR CHANNEL ERROR MESSAGE WAS DISPLAYED ON THE MEDIVATOR ENDOSCOPE REPROCESSOR EVERY TIME THE CUSTOMER TRIED TO REPROCESS THE SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138731 ↗
• MalfunctionSep 24, 2022Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA SIGMOIDOVIDEOSCOPE HAD ISSUES WITH THE AIR FLOW. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THE NOZZLE WAS CLOGGED. 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 15481478 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TECHNICAL AND CLINICAL SUCCESS RATES OF WALLFLEX DUODENAL STENTS IN UNRESECTABLE MALIGNANT GASTRIC OUTLET OBSTRUCTION. A RETROSPECTIVE OBSERVATIONAL STUDY FROM A TERTIARY CANCER HOSPITAL IN INDIA". THIS STUDY TO FIND THE TECHNICAL AND CLINICAL SUCCESS, AND COMPLICATION RATES OF DUODENAL STENTING IN SUCH PATIENTS PRESENTED AT INDIA¿S LARGEST TERTIARY CARE CANCER HOSPITAL. TECHNICAL AND CLINICAL SUCCESS RATES WERE 98.13% AND 91.42%, RESPECTIVELY. COMPLICATIONS INCLUDED BLEEDING IN 12, PANCREATITIS IN 4, AND SEDATION-RELATED COMPLICATIONS IN 25 OF THE PATIENTS. IN THE MEAN FOLLOW-UP PERIOD OF 120 DAYS, RECURRENCE OF OBSTRUCTIVE SYMPTOMS WAS OBSERVED IN 66 OF THE PATIENTS. TUMOR IN GROWTH IN 59.09%, FOOD IMPACTION IN 31.81%, AND MIGRATION OF THE STENT IN 15.15% OF PATIENTS WERE REASONS FOR RECURRENCE. THE MEDIAN TIME BETWEEN CLINICAL SUCCESS AND RECURRENCE OF OBSTRUCTIVE SYMPTOMS WAS 148 DAYS (95% CONFIDENCE INTERVAL (CI): 0¿328). PLACEMENT OF AN ENTERAL WALLFLEX STENT IN PATIENTS WITH MALIGNANT GOO IS A PRACTICAL, EASY, AND SAFE ALTERNATIVE TO SURGICAL GASTROJEJUNOSTOMY IN MALIGNANT GOO. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PROCE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Pancreatitis; Pneumonia

  MAUDE report 15106193 ↗
• MalfunctionApr 18, 2022Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  CUSTOMER SENT A REPAIR REQUEST REPORTED WITH A COMPLAINT DESCRIPTION OF SUCTION FUNCTION DOES NOT WORK. THE ISSUE FOUND DURING REPROCESSING. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. DEVICE EVALUATION FOUND FOREIGN MATERIAL EXITING IN THE DEVICE CHANNEL. THE A/W (AIR /WATER) CHANNEL WAS FOUND CLOGGED DUE TO FOREIGN MATERIAL BLOCKING THE CHANNEL. THIS REPORT IS BEING SUBMITTED FOR FOREIGN MATERIAL FOUND IN THE DEVICE CHANNEL , A/W CHANNEL CLOGGED WITH FOREIGN MATERIAL FOUND DURING DEVICE EVALUATION (REPORTABLE MALFUNCTION FOREIGN MATERIAL EXITING FROM THE CHANNEL, INSUFFICIENT REPROCESSING).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138752 ↗
• MalfunctionJun 18, 2021Device Reprocessing Problem; Device Reprocessing Problem

  DURING AN IN-SERVICE IN REPROCESSING OF EVIS EXERA SIGMOIDOVIDEOSCOPE, THE ENDOSCOPY SUPPORT SPECIALIST (ESS) OBSERVED A DEVIATION IN THE SCOPE CLEANING PROCESS AS THE FACILITY WAS NOT USING THE AIR WATER CHANNEL CLEANING ADAPTER AND WAS NOT FLUSHING THE AUXILIARY WATER CHANNEL AT PRE-CLEANING. THE ADAPTER IS AVAILABLE BUT WAS NOT USING IT. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12028833 ↗