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

Model Number CHF-CB30L

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 280474658
• Report Number: 8010047-2021-07522
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 04953170340154
• UDI-Public: 04953170340154
• Combination Product (y/n): N
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: CHF-CB30L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 06/28/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1