MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT260

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found no other reportable malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device evaluation, the gastrovideoscope exhibited foreign objects near the forceps stand (wire).There were no reports of patient involvement.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of 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.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation and the information provided, it could not be determined what the foreign material was.There was no damage to the area where the foreign material was detected, and it was unknown if reprocessing was performed according to the instructions for use (ifu).Therefore, the cause of the material remaining in the device could not be determined.As to the reprocessing procedures of the subject device, we checked the contents written in the instruction manual and found the following chapters.Phenomenon might be prevented by following these chapters.[instructions evis lucera ultrasound gastrovideoscope olympus gf type uct260].Chapter 6 compatible reprocessing methods.Chapter 7 cleaning, disinfection, and sterilization procedures.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE
• 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: 18871762
• MDR Text Key: 337845571
• Report Number: 3002808148-2024-02239
• Device Sequence Number: 1
• Product Code: ODG
• 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: 04/09/2024

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: GF-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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