MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CHOLEDOCHO VIDEOSCOPE; CHOLEDOCO VIDEOSCOPE

Model Number	CHF-V
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 olympus for evaluation.The customer's complaint for noisy image was not confirmed.In addition to b5, the repair center found the following defects: the angle wire became longer than normal, the resin was coming off of the insertion tube, buckled and deformed of the channel, and overall deterioration due to chemical and physical stress.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 or Problem Description
The customer reported to olympus the device presented an noisy image.Upon inspection and testing of the customer returned device, it was observed that the coating of the serpentine tube was peeled off.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
Correction to the initial medwatch.The aware date should be 18-jan-2022.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 11 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.The suggested phenomenon was presumed to have been due to stress of repeated use, external factors, or handling.It is recommended to the user to receive instruction on the method of handling regarding usage environment and so on.Olympus will continue to monitor field performance for this device.

• Brand Name: CHOLEDOCHO VIDEOSCOPE
• Common Device Name: CHOLEDOCO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13534318
• Report Number: 8010047-2022-02960
• Device Sequence Number: 19851859
• Product Code: FBN
• UDI-Device Identifier: 04042761062541
• UDI-Public: 04042761062541
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081456
• 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): 05/24/2022

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-V
• Device Catalogue Number: WA05991A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2010
• 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