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
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was not confirmed.In addition to the finds reported in event, due to a pinhole on bending section cover, water tightness was lost.Due to a pinhole on connecting tube, water tightness was lost.Due to a pinhole on channel tube, water tightness was lost.Connecting tube had a dent.Due to wear of angle wire, bending angle in up direction did not meet the standard value.The image guide bundle had significant breakages.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
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.
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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the coating of the insertion tube peeled due to stress of repeated use, external factors, or handling.The root cause of this event was unable to be identified.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 (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: 16120754
• Report Number: 9610595-2023-00381
• Device Sequence Number: 18282157
• 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): 02/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: CHF-CB30L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2015
• 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