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 Type  malfunction  

Event Description

A user facility returned the olympus oes choledochofiberscope to the service center due to a rubber tear.Upon inspection and estimation of the returned device, it was observed that the bending manipulation and insertion tube was defective with peeling of the coating from the insertion section.This report is being submitted for the even found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation uncovered the insertion part of the serpentine was crushed with the coating on the serpentine light guide peeling off.The bending angle was insufficient due to the elongation of the angle wire.The image guide bundle and the curved rubber were broken due to external forces.Additionally, the device visual field was cloudy and the eyepiece, upward plate, light guide and the universal cord leaked.The bending section cover was missing and there were stains on the light guide bundle due to external factor.The device universal code was wrinkled and scratched.The faulty parts need replacement to bring back to olympus functional standard.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.

Manufacturer Narrative

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 15 years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be established.It was concluded as a possible cause that there was excessive handling due to repeated wiping of the outer surface of the insertion part, chemical deterioration due to chemicals, etc.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The repair and complaint history was reviewed.Olympus will continue to monitor the field performance of this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 17-jan-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13544481
• MDR Text Key: 296377145
• Report Number: 8010047-2022-03066
• Device Sequence Number: 1
• Product Code: FBN
• UDI-Device Identifier: 04953170340154
• UDI-Public: 04953170340154
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K912120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1