ENDOSCOPE POSITION DETECTING UNIT UPD-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170331145), received between Oct 21, 2022 and Aug 24, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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. 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.

• MalfunctionAug 24, 2023Defective Component; Defective Component

  THE CUSTOMER REPORTED THE ENDOSCOPE POSITION DETECTING UNIT DISPLAYED ERROR CODE N907 (IMAGE PROCESSOR/LIGHT SOURCE DEFECT). THE ERROR WAS NOTICED BEFORE A DIAGNOSTIC PROCEDURE ON THE SCOPE GUIDE. THERE WAS A DELAY OF MORE THAN 15 MINUTES AND THE PROCEDURE WAS COMPLETED WITHOUT SCOPE GUIDE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17611416 ↗
• MalfunctionJun 8, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DEVICE MAY HAVE BEEN USED ON A PATIENT WITH A PACEMAKER. AT THAT TIME, THE DOCTOR RECOGNIZED THAT ITS USE WAS CONTRAINDICATED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090993 ↗
• MalfunctionNov 4, 2022Defective Device; Defective Device

  THE FIELD SERVICE COORDINATOR ON BEHALF OF THE CUSTOMER REPORTED, THE ENDOSCOPE POSITION DETECTING UNIT WAS NOT WORKING DURING A COLONOSCOPY DUE TO WHICH THE PROCEDURE HAD TO BE CANCELLED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15735269 ↗
• MalfunctionOct 21, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  THE CUSTOMER REPORTS DURING AN UNSPECIFIED PROCEDURE USING AN ENDOSCOPIC POSITION DETECTING DEVICE WITH A VIDEO SYSTEM CENTER, THE USER WAS UNABLE TO CAPTURE AN IMAGE. THERE WAS A 45-MINUTE DELAY IN THE PROCEDURE WHICH LEFT THE PATIENT IN PAIN. THE USER HAD TO CAPTURE THE IMAGE MANUALLY. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE. THE EQUIPMENT WAS INSPECTED ONSITE BY MEDICAL ENGINEERING. MEDICAL ENGINEERING CONFIRMED THAT THE SCOPE GUIDE HAD A LOOSE CONNECTION WHICH WAS RESOLVED BY THE HOSPITAL¿S STAFF ON SITE. THE VIDEO SYSTEM CENTER HAD ISSUES WITH THE SETTINGS WHICH HAS NOW BEEN RECTIFIED USING TECH SUPPORT. WITH THAT SAID MEDICAL ENGINEERING BELIEVE THAT THE ISSUE DID NOT LIE WITH THE EQUIPMENT. THE EQUIPMENT IS NOT BEING RETURNED TO OLYMPUS FOR EVALUATION SINCE THE ISSUES WERE CORRECTED ONSITE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE VIDEO SYSTEM CENTER USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE ENDOSCOPIC POSITION DETECTING DEVICE USED IN THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 15650453 ↗