MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC GASTROVIDEOSCOPE

Model Number GF-UE260-AL5

Device Problem Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed that during the device inspection, the gastrovideoscope exhibited ultrasound cover had foreign body.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.It has been over twelve (12) years since the subject device was manufactured.Based on the results of the investigation, a definitive root cause could not be determined.However, it is likely that unspecified ultrasound us cover foreign material on the ultrasound cover occurred due to confirmed physical damage on the forceps channel pinhole and curved rubber pinhole.The event can be prevented by following the instructions for use: chapter 6 compatible reprocessing methods and chemical agents chapter 7 cleaning, disinfection and sterilization procedures olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Type of Device: ULTRASONIC 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: 19002868
• MDR Text Key: 339336456
• Report Number: 3002808148-2024-02998
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GF-UE260-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2012
• 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