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 device was returned to an olympus repair facility and evaluated.Upon inspection and testing, peeled coating was discovered on the connecting tube.In addition, pinholes on the bending section cover and the channel tube caused water tightness to be lost.Chipped adhesive was discovered on the bending section cover, the connecting tube and universal cord had dents, the adhesive around the light guide lens was peeled, and a worn angle wire prevented the bending angle in the up direction from meeting standard value.The investigation is ongoing; therefore, a 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
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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation and correction h4.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 peeled coating on the connecting tube was caused by stress of repeated use, external factors, or handling of the device.The event can be detected/prevented by following the instructions for use which state: ¿¿chapter 3 preparation and inspection 3.2 inspection of the endoscope¿ as below.[inspection of the endoscope] 1.Visually inspect the control section for excessive scratching.2.Visually inspect the boot and the insertion tube near the boot for bends, twists or other irregularities.3.Visually inspect the surface of the insertion tube for dents, bulges, swelling, peeling or other irregularities.4.Carefully run your fingertips over the entire length of the insertion tube.Inspect for any protruding objects or other irregularities.¿ 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: 17454162
• Report Number: 9610595-2023-11108
• Device Sequence Number: 17957062
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 07/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2000
• 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