OES CHOLEDOCHOFIBERSCOPE OLYMPUS CHF TYPE CB30LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04953170340154), received between Jun 14, 2021 and Oct 29, 2024 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 25, 2023Class IIIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0330-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE COATING ON THE IMAGE GUIDE HOSE HAS PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559501 ↗
• MalfunctionApr 26, 2024Break; Break

  IT WAS REPORTED, THE OES CHOLEDOCHOFIBERSCOPE EXHIBITED A BROKEN OUTER SHEATH TIP. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192533 ↗
• MalfunctionAug 3, 2023Peeled/Delaminated; Peeled/Delaminated

  A CUSTOMER REPORTED DEFECTS ON THE BENDING RUBBER OF THE OES CHOLEDOCHOFIBERSCOPE. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. UPON INSPECTION AND TESTING, PEELED COATING WAS DISCOVERED ON THE CONNECTING TUBE. 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 17454162 ↗
• MalfunctionMar 28, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THEIR OES CHOLEDOCHOFIBERSCOPE HAD A PINHOLE IN THE BENDING SECTION COVER. UPON INSPECTION AND TESTING OF THE RETURNED UNIT, IT WAS DISCOVERED THAT THE CONNECTING TUBE COATING WAS PEELING. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. 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 16632340 ↗
• MalfunctionJan 9, 2023Peeled/Delaminated; Peeled/Delaminated

  AN OLYMPUS EMPLOYEE REPORTED A PINHOLE IN THE BENDING SECTION COVER OF A LOANER ASSET, OES CHOLEDOCHOFIBERSCOPE. THERE WAS NO REPORT OF USER OR PATIENT HARM ASSOCIATED WITH THIS EVENT. DURING INCOMING INSPECTION, IT WAS DETERMINED THE IMAGE GUIDE COIL COATING WAS PEELING. THIS MEDWATCH IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16120754 ↗
• MalfunctionSep 23, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THERE WAS A PINHOLE ON THE BENDING SECTION COVER (A-RUBBER) OF THE SUBJECT DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THE COATING ON THE INSERTION TUBE WAS PEELING OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING DEVICE EVALUATION (COATING PEELING OFF). ADDITIONAL DETAILS WERE REQUESTED REGARDING THE REPORTED EVENT; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473927 ↗
• MalfunctionJul 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED A PINHOLE LEAK. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. DURING INSPECTION AND TESTING, SERVICE FOUND A PIECE OF RUBBER COVERING HAD BEEN TORN OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND BY SERVICE DURING THE DEVICE EVALUATION [ADHESIVE DETACHED].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15131422 ↗
• MalfunctionFeb 16, 2022Break; Break

  A USER FACILITY RETURNED THE OLYMPUS OES CHOLEDOCHOFIBERSCOPE TO THE SERVICE CENTER DUE TO A RUBBER TEAR. UPON INSPECTION AND ESTIMATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE BENDING MANIPULATION AND INSERTION TUBE WAS DEFECTIVE WITH PEELING OF THE COATING FROM THE INSERTION SECTION. THIS REPORT IS BEING SUBMITTED FOR THE EVEN FOUND DURING EVALUATION. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13544481 ↗
• MalfunctionJun 14, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING CLEANING AFTER A COMMON BILE DUCT EXPLORATION PROCEDURE, IT WAS FOUND THAT THE ANGULATION WAS LOCKED AT 90 DEGREE. THE USER HAD COMPLETED THE INTENDED PROCEDURE WITH THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11996902 ↗