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

Model Number GF-UCT260

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Gastrointestinal Hemorrhage (4476)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

This report is related to the following linked patient identifier: (b)(6).The legal manufacturer's final investigation was completed.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The dhr confirmed that the subject device was released in accordance with the specifications.Based on the results of the investigation, the root cause of the phenomenon could not be identified.There was no damage to the device reported so it was determined that the device was in compliance with specifications.A review of the instructions for use and device labeling revealed no anomalies that could lead to the reported phenomenon.Olympus will continue to monitor field performance for this device.

Event Description

It was reported that during an endoscopic ultrasound-guided hepaticogastrostomy (eus-hgs), while using with an ultrasound gastrovideoscope and a single use aspiration needle, a puncture guidewire entered the patient's blood vessel instead of the target bile duct causing a delay of about 25 minutes.After bile duct dilation and stent placement, blood had accumulated in the gastrointestinal tract.The ultrasound gastrovideoscope was immediately removed since it could not aspirate the blood and replaced with another scope.The procedure was completed thereafter.The patient's status after the procedure was unknown.However, it was believed that the patient was given additional antibiotics since guidewires usually do not go into blood vessels.The physician reportedly also noted that even if the target bile duct was shown on the ultrasound image and the needle was taken out, the needle could not be seen and if you twist and put the needle in the screen, the bile duct will be displaced from its intended location.Further, the treatment tool would not show up in the optical image even if you take it out and it was not possible to capture the desired bile duct and needle on the same ultrasound screen.The suction on the scope was also weak.Multiple attempts to obtain additional information have been unsuccessful.

• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18768437
• MDR Text Key: 336120849
• Report Number: 3002808148-2024-01702
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2023
• 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
• Treatment: G-260-2545A/UNKNOWN LOT NO.; NA-U200H-8022/UNKNOWN LOT NO.; UNKNOWN STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female