MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT180

Device Problem Failure to Capture (1081)

Patient Problems Perforation (2001); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.There was no malfunction report of the subject device.According to the repair history of the subject device, no third party was involved in the repair.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) received a report that the perforation rate has increased at the user facility when olympus staff visited the user facility.The facility has performed 800 cases of endoscopic ultrasonography (eus) using two gf-uct180 untrasound gastrovideoscopes and two gf-ue160-al5 untrasound gastrovideoscopes.The perforation rate per year in the upper gastro area doubled in examinations with the subject device.The user facility states that the perforation rate is higher than other competitor products.The physician in the user facility stated that the characteristics of the subject device as follows would cause perforation.- endoscopic image of the subject device doesn't capture the distal tip of the ultrasound transducer.- balloon attachment groove shapes edge.Therefore, according to the number of the type of endoscope, omsc is submitting 4 medical device reports corresponding to the number of the device.This report is 1 of 4 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) was informed that four patients had perforation between the year 2017 and 2019.While the user facility has four different endoscopes, the model of endoscope used in each procedure is unknown.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.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Type of Device: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8715340
• MDR Text Key: 148535496
• Report Number: 8010047-2019-02237
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04953170356346
• UDI-Public: 04953170356346
• Combination Product (y/n): N
• PMA/PMN Number: K093395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GF-UCT180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1