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

Model Number CHF-V

Device Problem Material Integrity Problem (2978)

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

Event Date 11/13/2022

Event Type  malfunction  

Manufacturer Narrative

This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the insertion section coating of the choledocho videoscope was worn/damaged.The customer noted the coating was not peeling.The issue was found during inspection.The procedure was completed with the scope and there was no reported patient harm or impact due to this event.The scope was being sent to a third party for repair.

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, it is likely that the insertion section received physical stress from being hit, caught, or the like or that the insertion section was deteriorated by chemical stress.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): ifu warns against applying external stress to the insertion section as follows: ¿important information ¿ please read before use: warnings and cautions: do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.¿ ifu warns against bad environment of device storage as follows: ¿the storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature.Storing the endoscope in direct sunlight, at high temperatures, in high humidity or exposed to x-rays and ultraviolet-rays may damage the endoscope or present an infection control risk.¿ olympus will continue to monitor the field performance of 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: 15914572
• MDR Text Key: 305727128
• Report Number: 9610595-2022-04871
• 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: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/21/2022
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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