Gas/Water Valve MAJ-521Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170071478), received between Sep 4, 2019 and Jun 19, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THE AIR SUPPLY WAS INSUFFICIENT AND WATER REMAINED ON THE LENS SURFACE. IT WAS ALSO REPORTED THAT THE RUBBER PART APPEARED TO BE MISSING. THE REPORTED ISSUE OCCURRED WHILE PREPARING THE SUBJECT DEVICE FOR USE DURING A DIAGNOSTIC COLONOSCOPY PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THE VALVE WAS CLOGGED WITH FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION OF THE DEVICE (FOREIGN MATERIAL IN VALVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741378 ↗
• InjurySep 4, 2019Pressure Problem; Pressure Problem

  THE MANUFACTURER BECAME INFORMED THAT 24 HOURS AFTER A DIAGNOSTIC COLONOSCOPY PROCEDURE IN (B)(6) 2019, A PATIENT EXPERIENCED PAIN AND WAS INSPECTED. THE DOCTOR AT THE USER FACILITY INDICATED THAT THE PATIENT WAS DETERMINED TO HAVE A PERFORATED RECTUM AND THE DOCTOR BELIEVED THE INJURY TO THE PATIENT WAS CAUSED BY OVER PRESSURE FROM THE ENDOSCOPIC CO2 REGULATION UNIT AND GAS/WATER VALVE. THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL/SURGEON AND REQUIRED A EXPLORATORY LAPAROTOMY. THE PATIENT WAS HOSPITALIZED FOR A FEW WEEKS AND DISCHARGED AS THE PATIENT ALSO HAD A PRE-EXISTING CONDITION OF SEVERE ARTERIAL VASCULAR DISEASE IN THE LOWER EXTREMITIES THAT EVENTUALLY REQUIRED AMPUTATION OF ONE HIS LEGS. THE TECHNICIANS AT THE USER FACILITY PERFORMED A FUNCTIONAL INSPECTION PRIOR TO PROCEDURE AND THERE WERE NO ANOMALIES NOTED. THE DOCTOR NOTICED THAT THERE WAS PRESSURE BEING LOST AT THE TIME BUT WASN'T SURE WHAT IT WAS, BUT THE DOCTOR LATER BELIEVED IT TO BE PRESSURE BEING LOST FROM THE PERFORATION TO THE PATIENT. THIS IS FOR REPORT 2 OF 2.

  Patient problems: Bowel Perforation

  MAUDE report 8961074 ↗
• InjurySep 4, 2019Increase in Pressure

  THE MANUFACTURER BECAME INFORMED THAT 24 HOURS AFTER A DIAGNOSTIC COLONOSCOPY PROCEDURE IN (B)(6) 2019, A PATIENT EXPERIENCED PAIN AND WAS INSPECTED. THE DOCTOR AT THE USER FACILITY INDICATED THAT THE PATIENT WAS DETERMINED TO HAVE A PERFORATED RECTUM AND THE DOCTOR BELIEVED THE INJURY TO THE PATIENT WAS CAUSED BY OVER PRESSURE FROM THE ENDOSCOPIC CO2 REGULATION UNIT AND GAS/WATER VALVE. THE PATIENT WAS ADMITTED TO A DIFFERENT HOSPITAL/SURGEON AND REQUIRED A EXPLORATORY LAPAROTOMY. THE PATIENT WAS HOSPITALIZED FOR A FEW WEEKS AND DISCHARGED AS THE PATIENT ALSO HAD A PRE-EXISTING CONDITION OF SEVERE ARTERIAL VASCULAR DISEASE IN THE LOWER EXTREMITIES THAT EVENTUALLY REQUIRED AMPUTATION OF ONE HIS LEGS. THE TECHNICIANS AT THE USER FACILITY PERFORMED A FUNCTIONAL INSPECTION PRIOR TO PROCEDURE AND THERE WERE NO ANOMALIES NOTED. THE DOCTOR NOTICED THAT THERE WAS PRESSURE BEING LOST AT THE TIME BUT WASN'T SURE WHAT IT WAS, BUT THE DOCTOR LATER BELIEVED IT TO BE PRESSURE BEING LOST FROM THE PERFORATION TO THE PATIENT. THIS IS FOR REPORT 1 OF 2.

  Patient problems: Pain; Perforation

  MAUDE report 8961023 ↗