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 07/05/2021

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated at olympus (b)(4), and olympus (b)(4) confirmed the following: according to the repair history, the device was repaired on september 17, 2020.There was a leakage from the bending section.The insertion section was yellowish due to aging.Olympus medical systems corp.(omsc) could not confirm any defects that could cause the reported event from the device inspection result.The exact cause of the reported event could not be conclusively determined, because the device has not been returned to omsc.However, based upon the past similar cases, the reported event may have been caused by the application of some physical or chemical stress to the insertion section.Examples include physical stress such as rubbing the insertion section, chemical stress due to deviation from the reprocessing manual, poor storage environment such as direct sunlight, high temperature, high humidity, x-rays and ultraviolet rays, aging deterioration, etc.The instruction manual provides warnings about applying external stress to the insertion section, reprocessing method not recommended by the reprocessing manual, and storage of the endoscope in a harsh environment.Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.If additional information becomes available, this report will be supplemented.

Event Description

The user returned the device to olympus (b)(4) for repair due to a leakage from the bending section.Olympus (b)(4) then inspected the device and found that the coating of the insertion tube greater than 1x1 square millimeter was peeled off.There was no report of patient injury associated with the event.

• 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: 12257396
• MDR Text Key: 265638153
• Report Number: 8010047-2021-09596
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/02/2021

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: No Information
• Device Model Number: CHF-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1