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 Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found upward/downward angulation control knob (u/d knob) could not be locked securely due to the wear of the lock engagement lever, displayed ultrasound image was defective with missing elements due to damage on the ultrasonic probe, acoustic lens was damaged (damage level did not reach the glue-layer), distal end was deformed, adhesive around objective lens had wear, objective lens had a scratch, adhesive around light guide lens had wear, light guide bundle had breakage, adhesive on bending section cover had wear, connecting tube had a scratch, bending angle in up direction did not meet the standard value due to wear of angle wire, ultrasonic probe was loose, and universal cord had buckling.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, there was a channel four blocked when using the ultrasound gastrovideoscope.The issue was found during reprocessing.The device was returned for evaluation.During the device evaluation, foreign material was found exiting the nozzle due to insufficient cleaning and foreign objects came out of distal end was found.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction 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, it is likely that there is a possibility that before sending the device to olympus, reprocessing was not accomplished, and the foreign object remained.The event can be detected/prevented by following the instructions for use which state: about reprocessing method, it is described in the items below.From the description, the phenomena could be prevented: i) chapter 6 compatible reprocessing methods and chemical agents.Ii) 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: 18545994
• MDR Text Key: 333483255
• Report Number: 3002808148-2024-00597
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170287879
• UDI-Public: 04953170287879
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

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-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2011
• 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