Olympus WB950167Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04042768501678), received between Jan 20, 2021 and Oct 14, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Pumping Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE THE CUSTOMER WAS SEEING THE E26 ERROR ON THE DEVICE. IT WAS STATED THAT THE PROBLEM AFFECTED THE OUTCOME OF THE PROCEDURE BECAUSE THE PHYSICIAN WAS UNABLE TO USE THE PUMP DEVICE PROPERLY TO LIFT TISSUE FOR CUTTING. ADDITIONALLY, THERE WAS A DELAY AS THERE WERE MANY ADDITIONAL DEVICE EXCHANGES TO INJECTION NEEDLES AS THEY WERE NEEDED TO ¿LIFT TISSUE FOR CUTTING¿, WHICH CAUSED THE PROCEDURE TO TAKE MUCH LONGER. THE SECOND LESION SITE WAS ALSO NOT ATTEMPTED DUE TO TIME CONSTRAINTS. OVERALL, THE PROCEDURE WAS LESS SUCCESSFUL THAN DESIRED AND NOT FULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446807 ↗
• InjuryOct 14, 2024Pumping Problem; Pumping Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE THE CUSTOMER WAS SEEING THE E26 ERROR ON THE DEVICE. IT WAS STATED THAT THE PROBLEM AFFECTED THE OUTCOME OF THE PROCEDURE BECAUSE THE PHYSICIAN WAS UNABLE TO USE THE PUMP DEVICE PROPERLY TO LIFT TISSUE FOR CUTTING. ADDITIONALLY, THERE WAS A DELAY AS THERE WERE MANY ADDITIONAL DEVICE EXCHANGES TO INJECTION NEEDLES AS THEY WERE NEEDED TO ¿LIFT TISSUE FOR CUTTING¿, WHICH CAUSED THE PROCEDURE TO TAKE MUCH LONGER. THE SECOND LESION SITE WAS ALSO NOT ATTEMPTED DUE TO TIME CONSTRAINTS. OVERALL, THE PROCEDURE WAS LESS SUCCESSFUL THAN DESIRED AND NOT FULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446482 ↗
• InjuryMar 19, 2021Failure to Power Up; Failure to Power Up

  OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED EMERGENCY PROCEDURE, WHERE THE PERISTALTIC PUMP UNIT AFU-100 WAS USED FOR FLUSHING DUE TO BLEEDING, THE DEVICE COULD NOT BE PUT INTO OPERATION LEADING TO A SIGNIFICANT PROLONGATION OF THE PROCEDURE AND HIGH BLOOD LOSS OF THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11526212 ↗
• MalfunctionJan 20, 2021Image Display Error/Artifact; Image Display Error/Artifact

  AS REPORTED, DURING PROCEDURE PREPARATION, THE OLYMPUS AFU-100 DISPLAYED ERROR MESSAGE E24. THERE WAS NO PATIENT HARM OR CONSEQUENCE AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11204861 ↗