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

Model Number GF-UE160-AL5

Device Problem No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned.Should additional relevant information become available, a supplemental report will be submitted.Three attempts were performed to obtain additional information, but no response was received from the customer.

Event Description

It was reported, there was a loss of part of the ultrasound image on the gastrovideoscope.The issue occurred during a procedure.There were no reports of patient harm.

• 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: 18834838
• MDR Text Key: 336873363
• Report Number: 3002808148-2024-02040
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356261
• UDI-Public: 04953170356261
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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