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

Model Number GF-UCT260

Device Problems Break (1069); Peeled/Delaminated (1454); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found additional reportable findings: the adhesive was peeling off of tip lid fixing screw, ultrasonic probe surface insulation failure, and a foreign body near the forceps stand.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device inspection, the ultrasound gastrovideoscope exhibited the tip rubber cover was broken.There were no reports of patient involvement.

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 root cause of the event was unable to be identified.The foreign material was unable to be identified.The actual product is cleaned, disinfected, and sterilized before being sent to olympus, and the reprocessing method does not deviate significantly from the instruction manual.There was no equipment abnormality near the forceps stand (wire), which is the location where foreign matter was attached.Additionally, the adhesive peeling and the acoustic lens damage likely occurred due to a physical stress by dropping and/or knocking the affected part to a hard surface/object and applying a chemical stress during the cleaning/sanitization.The event can be detected/prevented by following the instructions for use which are described in the following chapters: chapter 6 application and conditions of cleaning, disinfection, and sterilization and chapter 7 cleaning, disinfection, and sterilization procedures.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: 18926880
• MDR Text Key: 338187644
• Report Number: 3002808148-2024-02536
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2012
• 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