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

Model Number GF-UCT180

Device Problem Poor Quality Image (1408)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed; the image was blurry due to a defective charged coupled device unit.Additional findings include; due to wear of the angle wire, the bending angle in down, right, and left direction did not meet the standard value.Due to wear of the forceps elevator lever, the up/down knob could not be locked securely.Due to wear of angle wire, the play of up/down knob was out of the standard value.Adhesive on bending section cover had a discolored area.Connecting tube was deformed and coating was peeling.Forceps elevator lever and objective lens had a scratch.Adhesive on bending section cover had a discolored area.Switch box is deformed and suction cylinder had discoloration.Due to damage on acoustic lens, water tightness was lost.Because guide pin of el-connector is shaved, water tightness was lost.Due to damage on ultrasonic cable, the number of missing element exceeded the standard value.Ultrasonic probe was loose.Additional information has been requested regarding this event.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The customer reported to olympus that the objective lens was detached and image was darkened.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the acoustic lens was damaged.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Event Description

Additional event information reported by the customer: the event occurred during preliminary testing of the instrument, prior to a biliopancreatic echoendoscopy oprocedure.There was an approximate 10 minute delay in order to dismantle the non-performing echoendoscope and assemble the new instrument; the delay was not clinically relevant.The procedure was completed with another device and there was no patient harm.

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 damaged acoustic lens issue could not be determined, however, it the issue was likely the result of repetitive use stress and or user handling/mishandling.The event may be detected by following the instructions for use section below: chapter 3 preparation and inspection¿ section 3.3 ¿inspection of the endoscope.Inspection of the endoscope 6 inspect the objective lens and light guide lens at the distal end of the endoscope for scratching, cracks, stains, gaps around the lens, or other irregularities.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: 18288705
• MDR Text Key: 330014617
• Report Number: 3002808148-2023-13929
• Device Sequence Number: 1
• Product Code: ODG
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• 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: 11/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2020
• 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