MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CHOLEDOCHOFIBERSCOPE; CHOLEDOCHO FIBERSCOPE

Model Number	CHF-CB30L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during cleaning after a common bile duct exploration procedure, it was found that the angulation was locked at 90 degree.The user had completed the intended procedure with the subject device.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
The subject device is planned to be returned to olympus but has not been returned to olympus yet.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation result and correct in the initial report.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.As a result of evaluating the subject device, omsc concluded that the reported event was not reportable event.

• Brand Name: OES CHOLEDOCHOFIBERSCOPE
• Common Device Name: CHOLEDOCHO FIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11996902
• Report Number: 8010047-2021-07522
• Device Sequence Number: 3329023
• Product Code: FBN
• UDI-Device Identifier: 04953170340154
• UDI-Public: 04953170340154
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1