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

Model Number GF-UE160-AL5

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

Patient Problem Perforation (2001)

Event Date 04/15/2020

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the user facility noticed the perforation of the patient's duodenum during the endoscopic ultrasound (eus).The user facility did not provide other detailed information.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the subject device.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

Event Description

The following additional information was received: it was confirmed that the patient was reportedly doing "very well" and that the perforation did not represent a deterioration of health.The patient will be discharged after being treated as an inpatient.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to the following fields to include information that was inadvertently not included on the previous submission: a1, b5, d4, d8, e1, e2, e3, g2, h4 and h6.In addition, this supplemental report includes a correction to the lm investigation findings previously submitted.Based on the results of the investigation, although it was previously reported that the root cause could not be determined, the reported event was likely caused by the following: 1.The angle was forcibly hung, suddenly operated, pulled or twisted while the angle was hung.2.The endoscope was inserted and removed while the curvature of the endoscope was fixed.3.Various operations were performed without viewing endoscopic images.4.Various operations were performed while freezing the endoscopic image on the monitor.The event can be detected/prevented by following the instructions for use (ifu) which state: "warnings and cautions: follow the warnings and cautions given below when handling this instrument.This information is to be supplemented by the warnings and cautions given in each chapter." "warning: never perform angulation control forcibly or suddenly.Never forcefully pull, twist or rotate the angulated bending section.Patient injury, bleeding and/or perforation can result."" olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3002808148.

• 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; okakura, nishigo-mura; nishishirakawa-gun 961-8 061; JA 961-8061
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10055411
• MDR Text Key: 190936553
• Report Number: 8010047-2020-02697
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K051541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 07/24/2020; 04/25/2023; 05/03/2024
• Supplement Dates FDA Received: 08/19/2020; 05/10/2023; 05/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other