MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE; ULTRASOUND GASTROVIDEOSCOPE

Model Number GF-UCT240-AL5

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

Patient Problem Shock (2072)

Event Type  Injury  

Manufacturer Narrative

The subject device was not been returned to olympus medical systems corp (omsc).Omsc identified the serial number of the subject device as (b)(4) from the operational status of the user facility.The malfunction of the subject device concerning this case has not been reported.The exact cause could not be determined.

Event Description

Olympus medical systems corp.(omsc) received a literature titled ¿treatment results of 9 patients who underwent pancreatic pseudocyst drainage under eus-guided drainage¿.This literature was presented at the 98th congress of the japan gastroenterological endoscopy society; japan digestive disease week 2019, digital poster sessions 81.The literature reported that eus-guided drainage using an olympus endoscope gf-uct240 (omsc presumed to be gf-uct240-al5) was performed on 9 patients with symptomatic pancreatic pseudocysts.In the subject cases, 1 case of endotoxin shock occurred as accidental symptom, but the patient of this case was relieved by conservative treatment.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.

• Brand Name: ULTRASONIC 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9471221
• MDR Text Key: 187267164
• Report Number: 8010047-2019-04331
• 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: health professional,study,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GF-UCT240-AL5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other