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  

Event Description

The customer reported to olympus, that the evis lucera ultrasound gastrovideoscope had an air leakage.It is unknown when the issue was found and there is no known procedure information.The device was returned for evaluation.During the device evaluation the following was found; residual liquid or foreign material came out of the channel-tube and the distal end had foreign objects.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during the evaluation.

Manufacturer Narrative

The device was returned and evaluated.In addition to the malfunction documented in b5, the additional evaluation findings are as follows: due to a pinhole on the ch-tube, water tightness was lost; due to the wear of the angle wire, the bending angle in the up direction did not meet the standard value; due to the wear of the forceps lever, the up/down knob could not be locked securely; the control unit had corrosion due to water leakage; damage or deformation due to physical stress; the ultrasonic transducer had corrosion and the connecting tube and switch had scratches.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. .

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 in the channel tube and distal end of the device could not be identified and a definitive root cause of the issue could not be determined, however, due to the observed leak in the channel tube, it is possible that proper reprocessing could not be performed.The issue may be detected/prevented by following the instructions for use below: instruction manual 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: the device was cleaned, disinfected, and sterilized before being sent to olympus.No delay in the start of pre-cleaning.No abnormalities in the accessories used for reprocessing.The air/water nozzle was wiped/brushed with clean lint free cloths, brushes, or sponges.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: 18395322
• MDR Text Key: 331533860
• Report Number: 3002808148-2023-14824
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2013
• 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