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

Model Number TGF-UC260J

Device Problem Defective Component (2292)

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

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.During the evaluation it was found that the acoustic lens was peeled, (damage level; exposed glue-layer).The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is provided by the user facility.

Event Description

The customer reported to olympus that the probe was damaged, while using the ultrasound gastrovideoscope.The patient was not under anesthesia.There were no reports of delay, patient injury, or death associated with the event.

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, a definitive root cause of the observed scratched acoustic lens issue could not be determined, however, the issue was likely due to stress as a result of user impact during user handling/mishandling and or chemical stress during the device cleaning/reprocessing process.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: 18344577
• MDR Text Key: 330782031
• Report Number: 3002808148-2023-14381
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• 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: 12/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2015
• 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