MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OES CHOLEDOCHO FIBERSCOPE

Model Number CHF-P60

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.The benign cover was found leaking.Additionally, as noted , the coating material on the insertion section was peeling off.There were also more than 10 black dots noted in the imaging.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer reported that while performing routine maintenance on his olympus oes choledocho fiberscope, it was discovered that the device was leaking.There was no patient involvement during this event.During the device evaluation, it was discovered that the coating material was peeling off the unit.This report is being submitted to capture the peeling coating found during the device evaluation.

Manufacturer Narrative

Correction: e2 was inadvertently selected on the initial report.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 root cause of the event was unable to be identified; however, it was confirmed that the coating on the insertion part had peeled off.The event likely occurred due to physical stress/chemical stress/storage environment, etc.Are presumed to be the cause.The event can be detected/prevented by following the instructions for use which state: 1) "inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities." 2) "warning: do not strike, bend, hit, pull, twist, or drop 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, such as burns, bleeding, and/or perforation.It could also cause parts of the endoscope to fall off inside the patient." 3) "this instrument is not durable, or does not have sufficient durability against the respective methods stated in the guidelines of each country for destroying or inactivating prions.For information on the durability against each method, please contact olympus.If cleaning, disinfection and sterilization methods not stated in this instruction manual are performed, olympus cannot guarantee the effectiveness, safety and durability of this instrument.Make sure to confirm that there is no abnormality before use, and use under responsibility of a physician.Do not use if any abnormality is found." 4) "warning: 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 ozone, x-rays and/or ultraviolet-rays may damage the endoscope or present an infection control risk." olympus will continue to monitor field performance for this device.

• Brand Name: OES CHOLEDOCHO FIBERSCOPE
• Type of Device: CHOLEDOCHO FIBERSCOPE
• 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: 16130664
• MDR Text Key: 308869836
• Report Number: 9610595-2023-00487
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K843084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2023

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-P60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/21/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2018
• 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