MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number UNKNOWN

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

Patient Problems Death (1802); Blood Loss (2597)

Event Type  Death  

Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.Since the serial number of the subject device is unknown and omsc could not confirm the manufacturing history (dhr).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 italy (oit) became aware of an article in a journal about an unexpected death of a patient.According to the article, the patient was admitted to the user facility for pancreatitis in (b)(6) 2019.The patient underwent endoscopic retrograde cholangiopancreatography (ercp) using an unspecified duodenoscope on (b)(6) 2019, with good results.Later on, the patient underwent another endoscopy using an unspecified gastroscope and had a hematemesis.The patient died due to this fatal hematemesis.After the event, the hospital was ordered to perform an autopsy of the patient by italian deputy prosecutor.The article does not directly indicate that olympus products were used for procedures.However, it is most likely that these procedures were performed with olympus endoscopes since the user facility is only using olympus endoscopes.Oit contacted the user facility in order to get detailed information on the event.The head of endoscopy department at the user facility has excluded that there may be a correlation with the videoduodenoscope and the videogastroscope used in this event.The model number and serial number of the endoscopes used for the procedures are unknown.Oit asked the user facility to send the endoscopes back to oit, but the user facility has not responded yet.Omsc is submitting two medical device reports according to the number of the endoscopes that were most likely used for the patient.This is for the unspecified olympus gastroscope and two of two reports.

Manufacturer Narrative

This supplemental report is being submitted to update the block h6 of this form as well as to provide additional information.Olympus has not received information on there was failure of the device, from the user facility.The exact cause of the reported event could not be determined.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9698633
• MDR Text Key: 178737439
• Report Number: 8010047-2020-01307
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR