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

Model Number GF-UE260-AL5

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and the evaluation found the interruption in the ultrasound image occurred due to damage on the ultrasonic probe.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the gastrovideoscope exhibited an interruption in the ultrasound image.It is unknown when the issue was found.There were no reports of patient harm.

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 customer complaint of "interrupted ultrasound image" was not confirmed by olympus; however, the possibility of its occurrence cannot be denied.The event can be detected/prevented by following the instructions for use which state: "ultrasonic gastrovideoscope olympus gf type ue260-al5 for safe use handling and general precautions ¿ do not bend, hit, pull, twist, or drop the endoscope tip, insertion section, curved section, operating section, universal cord, scope connector, ultrasound cord, or ultrasound connector with strong force.Please.Doing so may damage the device, causing injury to the body cavity, burns, bleeding, perforation, or falling parts.¿ do not apply shock to the tip of the endoscope, especially the ultrasound probe and lens surface.This may cause abnormalities in ultrasound images and endoscopic images.¿ do not grasp the ultrasound transducer when holding the insertion tube.The ultrasound probe may be damaged and a normal ultrasound image may not be obtained.¿ do not twist or bend the curved part by hand.There is a risk of damage.¿ do not squeeze the curved part too hard.The covering material on the curved part may stretch or tear, causing water leakage." 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18907497
• MDR Text Key: 337795913
• Report Number: 3002808148-2024-02440
• 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
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UE260-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2009
• 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