MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. DUODENOFIBERSCOPE FOR ULTRASONIC SURVEY; ULTRASOUND GASTROVIDEOSCOPE

Model Number TGF-UC260J

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and repair.The investigation is still in progress.Therefore, the root cause of the reported defect cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.In general, the customer is required to inspect the device for defects.Check the function of all devices.And have alternate equipment prior to use.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported, that olympus staff found a foreign object during inspection of a duodenofiberscope.There was no patient injury or adverse event reported to olympus.

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 root cause of the event was unable to be identified; however, it is likely that the foreign object could not be removed due to physical damage to the equipment.It was confirmed that a pinhole had occurred in the forceps channel due to mishandling by the facility.There were no obvious deviations in reprocessing.The device was evaluated where no abnormalities were found that could have caused or contributed to the event.A few defects were noted where the probe immersion, angle play, insufficient angle, poor body ground continuity, corrosion inside the operating part, light guide snake tube scratch, and bending section rubber adhesive float.However, these defects alone are not considered severe enough to cause a potential adverse event.The event can be detected/prevented by following the instructions for use which state: 1) "do not open the tip of the treatment instrument inside the forceps channel of the endoscope or pull the tip of the treatment instrument out of the sheath.The forceps channel or instrument may be damaged." 2) "when the bending part of the endoscope is greatly curved, the force required to insert/remove the treatment instrument becomes large.If it is difficult to insert/remove the treatment instrument, return the bending angle of the bending part to a point where insertion/removal can be done without difficulty.Forcible insertion/removal may damage the forceps channel and the instrument." 3) "check that the tip of the treatment instrument is closed or retracted into the sheath, and then slowly insert or withdraw the instrument into the forceps plug.Also, do not open the tip of the treatment instrument or pull it out of the sheath while it is being inserted into the forceps channel of the endoscope.The forceps channel and treatment tools may be damaged." olympus will continue to monitor field performance for this device.

• Brand Name: DUODENOFIBERSCOPE FOR ULTRASONIC SURVEY
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16828449
• MDR Text Key: 314216020
• Report Number: 3002808148-2023-04336
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2023

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: TGF-UC260J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2023
• Initial Date FDA Received: 04/27/2023
• Supplement Dates Manufacturer Received: 05/07/2023
• Supplement Dates FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2018
• 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