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

Model Number GF-UCT180

Device Problem Failure to Clean Adequately (4048)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated by olympus.In addition to the findings in b5, evaluation found the up/down knob could not be locked securely due to wear of the forceps elevator lever, water tightness was lost due to deformation of the electrical connector guide pin, the displayed ultrasound image was defective with missing elements due to damage on the ultrasonic probe, the distal end was deformed, the bending section cover adhesive was worn, and the bending angle in the up direction did not meet the standard value due to wear of the angle wire.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported that air insufflation via the valve of the evis exera ii ultrasound gastrovideoscope did not work.Several valves were tested during the procedure.There was no reported patient harm or impact due to this event.During device evaluation at olympus, it was found foreign material exiting the air/water nozzle and distal end.The report is being submitted due to foreign material found during evaluation.

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 foreign material could not be identified nor the root cause of it.The event can be detected/prevented in accordance with the following instructions for use: chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection, and sterilization procedures olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 18586120
• MDR Text Key: 333900468
• Report Number: 3002808148-2024-00792
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2019
• 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