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

Model Number GF-UCT260

Device Problem Use of Device Problem (1670)

Patient Problems Death (1802); Perforation (2001)

Event Date 08/12/2020

Event Type  Death  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

The patient underwent a stomach examination using this endoscope and evis eus endoscopic ultrasound center eu-me2 premier plus.During the procedure, the patient's stomach was perforated and the patient died.There is no information on how the hospital treated the perforation or how the perforation led to the death.According to a nurse of the hospital, this event was likely to be a clinical technique issue, not a product problem.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The physical device was not returned to olympus for investigation.An olympus service representative followed-up with the customer and confirmed that the routine inspection performed on september 5th on didn't find any problem on the device after the event occurred.Olympus also received information suggesting that the user facility didn't use clips or perform a surgery to treat the perforation and the hospital didn't allege the device's malfunction.Device history record shows no irregularity on the device.Based on the above, olympus assumes that the device did not cause the patient death.

• Brand Name: EVIS LUCERA 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: 10533049
• MDR Text Key: 206917297
• Report Number: 8010047-2020-06504
• Device Sequence Number: 1
• Product Code: ODG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death