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

Model Number	CHF-CB30L
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, the reported issue (pinhole on a-rubber) was confirmed and found to be caused by external factors.It was observed there was a leakage due to holes in the a-rubber.In addition to coating peeling off, service found the flexible tube of the insertion section was crushed.Scratches were observed on the eyepiece, and the angle lever due to external factors.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
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.
Additional 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 of the reported event is unable to be determined.However, the cause of the event is likely due to the coating of insertion tube was peeled off by stress of repeated use, external factors, or handling.Olympus will continue to monitor field performance for this device.

• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Common Device Name: CHOLEDOCHO FIBERSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15473927
• Report Number: 9610595-2022-02155
• Device Sequence Number: 4323055
• Product Code: FBN
• UDI-Device Identifier: 04953170340154
• UDI-Public: 04953170340154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K912120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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
• Operator of Device: Health Professional
• Device Model Number: CHF-CB30L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown