MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES CHOLEDOCHOFIBERSCOPE; CHOLEDOCHO FIBERSCOPE

Model Number CHF-CB30L

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

In addition to the coating of the insertion section peeling, service confirmed that the bending section cover had a tear and a pinhole.Service also found there was a pinhole in the forceps channel, the insertion guide bundle had a break, and there was insufficient angulation due to a stretched angle wire.The insertion tube was collapsed.During inspection and testing, a brush and treatment instrument would get caught in the instrument channel, due to buckling and deformation of the channel.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.

Event Description

The oes choledochofiberscope (subject device) is an olympus loaner device that was returned to an olympus service center with a report that the bending section cover (a-rubber) was cracked.There was no patient or user harm reported.During inspection and testing of the returned device, service found the coating of the insertion section was peeling.This report is being submitted for the reportable malfunction found during the device evaluation (peeling coating).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be determined.It is likely the event was caused by stress from repeated use, external factors, or handling.The event can be detected by following the instructions for use (ifu) which state: "1.Visually inspect the control section and the light guide connector for excessive scratching.2.Visually inspect the boot and the flexible tube near the boot for bends and twists or other irregularities.3.Visually inspect the surface of the insertion portion for dents, bulges or other irregularities.4.Carefully run your fingertips over the entire length of the insertion portion.Inspect for any protruding objects, internal looseness or other irregularities (see figure 3.2)." olympus will continue to monitor field performance for this device.

• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Type of Device: CHOLEDOCHO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16386840
• MDR Text Key: 310152633
• Report Number: 9610595-2023-02660
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CHF-CB30L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1