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

Model Number GF-UCT260

Device Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device will not be returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.Related patient identifiers: (b)(6).

Event Description

An olympus sales supervisor reported on behalf of the customer that the evis lucera ultrasound gastrovideoscope was incorrectly reprocessed in a reprocessor which could not drain water sufficiently during replacement of the water filter.There were no reports of patient or user harm associated with this event.Parent patient identifier: (b)(6) and another related patient identifiers: (b)(6).

Manufacturer Narrative

Updated: h6, h10 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 root cause of the facility reprocessing the scope using an oer-6 automatic endoscope reprocessor without replacing the water filter at the recommended time interval, as stated in the ifu, was determined to be due to facility/user error.The event can be prevented by following the instructions for use which state: chapter 7: tasks to be performed monthly or weekly as needed.7.3 replacing the water filter (maj-2317) ¿to prevent contamination of the rinse water, replace the water filter regularly, at least once every two months.Also, replace it if an error code [e01] is displayed due to insufficient water supply.Notice water filters should be replaced at least once every two months.If the performance of the water filter deteriorates, bacteria in the tap water may not be removed sufficiently, potentially contaminating the equipment pipes¿.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: 17667396
• MDR Text Key: 322545171
• Report Number: 3002808148-2023-09293
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2021
• 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
• Treatment: OER (OLYMPUS ENDOSCOPE REPROCESSOR)