MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. CHOLEDOCHO VIDEOSCOPE; CHOLEDOCO VIDEOSCOPE

Model Number CHF-V

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Event Description

The customer reported to olympus the choledocho videoscope exhibited leakage of bending part.The issue was found during the preparation for use for an unspecified diagnostic procedure.The procedure was completed using a similar device.There were no reports of patient or user harm associated with this event.  during testing and inspection of the returned device revealed that the connecting tube coating was peeling.(1mm2 or more).This medical device report (mdr) is being submitted to capture the reportable malfunction found during device evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the following; the bending section cover or distal sheath was not waterproof due to perforations; the connecting tube was wrinkled; the angle of curvature in the upwards direction did not meet the specification due to wear of the angle wire; the coating on the connecting tube was peeling off; and the inside light guide lens had a stain.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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.Based on the results of the investigation, the definitive root cause of the peeled coating could not be determined.It is possible that the peeled coating was caused by physical stress, environmental stress such as direct sunlight, high temperatures, high humidity, and x-rays, or chemical stress through conducting reprocessing methods that is not recommended in the instruction manual.Detection methods for preventing the coating peeling issue are written in chapter 3, section 3.2 of the instruction manual.Preventative methods are written in chapter 5, section 5.2, chapter 6, section 6.1, and chapter 9, section 9.1 olympus will continue to monitor field performance for this device.

• Brand Name: CHOLEDOCHO VIDEOSCOPE
• Type of Device: CHOLEDOCO VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17153372
• MDR Text Key: 317845836
• Report Number: 9610595-2023-09010
• Device Sequence Number: 1
• Product Code: FBN
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K081456
• 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
• Report Date: 07/26/2023

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-V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/21/2023
• Initial Date FDA Received: 06/19/2023
• Supplement Dates Manufacturer Received: 07/05/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2012
• 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