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 to olympus for evaluation and the evaluation found additional non-reportable findings: due to damage on ultrasonic probe the displayed ultrasound image was defective with missing elements, due to damage on acoustic lens the water tightness was lost, due to wear of angle wire the bending angle in up direction and the play of upward and downward knob (u/d knob) did not meet the standard value, bending section cover (a-rubber) has discoloration, adhesive on a-rubber was detached, had a chip and a crack, suction connector (s-connector) was sticky, elevator channel plug was loose, adhesive around objective lens was peeled, acoustic lens was damaged, there was a chip in adhesive area between acoustic lens and ultrasound probe, due to damage on acoustic lens the water tightness was lost.The investigation is ongoing and 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, the ultrasound gastrovideoscope had weak echo at 8:00 o'clock direction.The issue was found during an unknown procedure.The device was returned for evaluation.During the device evaluation, the scope connector had foreign body 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, the observed foreign material on the scope connector could not be identified and a definitive root cause of the issue could not be confirmed, as there was no deformation observed that might result in the retention of foreign material, however, it is unknown if the facility wiped/brushed outer surface of the endoscope with the gauze brush or sponge in accordance with the ifu.The issue was likely the result of insufficient device cleaning/reprocessing.The issue may be detected/prevented by following the instructions for use sections below: evis lucera ultrasonic gastrovideoscope olympus gf type uct260 ·chapter 6 application and conditions of cleaning, disinfection, and sterilization ·chapter 7 cleaning, disinfection, and sterilization procedures reprocessing survey info: - was the device cleaned, disinfected, and sterilized before being sent to olympus? - unknown.- was there a delay in the start of pre-cleaning? ¿ no.- did the customer aspirate the water through the instrument/suction channel? - unknown.- were there any abnormalities in the accessories used for reprocessing? - no.- did not soak the endoscope in cleaning solution - unknown.- was the air/water nozzle wiped/brushed with clean lint free cloths, brushes, or sponges? ¿ unknown.- did the customer brush the instrument channel, instrument channel port, and suction cylinder? - unknown.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: 18430049
• MDR Text Key: 331984989
• Report Number: 3002808148-2024-00028
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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: 12/10/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2014
• 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