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

Model Number CHF-V

Device Problem Break (1069)

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

Event Date 10/08/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to (b)(4).(b)(4) checked the subject device and found the reported phenomenon (coating peeling), and also found that this phenomenon was attributed to the deterioration.The exact cause has been under investigation.Therefore, 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.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during the reprocessing for hepatobiliary examination using the subject device in combination with the video processor cv-190, it was found that the bending section cover of the subject device was leaked.The user completed the intended procedure using the subject device without more than fifteen minutes extension.(b)(4) found that the coating of the insertion tube had been partially peeled off more than 1mm2 during the incoming inspection for the repair of the subject device.There was no report of patient injury associated with this event.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to olympus china.Olympus medical systems corp.(omsc) reviewed, the manufacturing history (dhr) of the subject device and confirmed, no irregularity.The exact cause of the reported phenomenon (coating peeling) could not be conclusively determined.However, based upon the information from olympus china, osmc surmised, that this phenomenon was attributed to the physical stress, chemical stress, or storage environment.If additional information is received, this report will be supplemented.

• Brand Name: CHOLEDOCHO VIDEOSCOPE
• Type of Device: 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: 12778581
• MDR Text Key: 280541958
• Report Number: 8010047-2021-14331
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081456
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CHF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1