MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE; ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UE190

Device Problem Failure to Clean Adequately (4048)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus and evaluated.In addition to the reportable malfunction of foreign material in the connecting tube unit, the evaluation found non-reportable device malfunctions/conditions.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was observed during the olympus device evaluation, the gastrointestinal videoscope had foreign material in the connecting tube unit.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.The legal manufacture reviewed the customer provided the cleaning disinfection and sterilization processes where no obvious deviations from instructions for use were identified.Based on the results of the investigation, olympus confirmed foreign material came out of the device, but the type of the material or root cause cannot be identified.A definitive root cause was not identified, however based on the results of the investigation, the probable cause of the malfunction would likely be due to deformation of the insertion part, connection between bending part and insertion part is unstable.The event can be prevented by following the instructions for use: chapter 4 reprocessing workflow for endoscopes and accessories.Chapter 5 reprocessing the endoscope (and related reprocessing accessories).Chapter 6 reprocessing the accessories.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE
• 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: 18957332
• MDR Text Key: 339118136
• Report Number: 3002808148-2024-02743
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UE190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2021
• 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