MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

Model Number UNKNOWN

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

Patient Problems Fever (1858); Sepsis (2067); Multiple Organ Failure (3261); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/05/2021

Event Type  Death  

Manufacturer Narrative

Health effect clinical code appropriate term: delirium.The exact olympus device model/serial number is unknown at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

The following information was reported to olympus regarding a press release involving one patient, titled: medical accidents that resulted in death after endoscopic treatment for early-stage gastric cancer.A medical accident occurred after an endoscopic submucosal dissection (esd) treatment for early gastric cancer.One day after esd, delirium symptoms and fever appeared.The attending physician attributed the cause of delirium to environmental changes and cause of fever to esd.It was judged to be due to post coagulation syndrome.The fever tended to be relived day by day and the delirium continued but judging that there was a high possibility that the patient's life would improve, patient was discharged from the hospital 4 days after esd.A day after discharge, the patient's awareness level was declining.The patient's family consulted by phone in the emergency room, however the nurse who answered did not give clear instructions hence, the family called for an ambulance.The patient was taken to a hospital for cardiopulmonary resuscitation and pronounced dead on the same day, at the hospital.Blood culture was done, as reported and unspecified bacteria was detected.According to the press release, the patient died due to multiple organ failure due to sepsis.The facility admitted that there was a misjudgment in the content of the procedure and in the treatment after the procedure.It is unknown what devices were used for the esd procedure.However, a customer from the facility reported the event to olympus and therefore, it is likely olympus devices were used in the procedure.Patient identifier (b)(6) will report evis lucera gastrointestinal videoscope as representative scope for this event.Patient identifier (b)(6) will report single use 3-lumen sphincterotome v as treatment tool representative for this event.It is unknown what devices were used for the esd procedure.However, a customer from the facility reported the event to olympus and therefore, it is likely olympus devices were used in the procedure.Patient identifier (b)(6) will report evis lucera gastrointestinal videoscope as representative scope for this event.Patient identifier (b)(6) will report single use 3-lumen sphincterotome v as treatment tool representative for this event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the cause of the reported event was due to the patient developing sepsis due to an infection, which later led to multiple organ failure.It is likely that the root cause was related to the patient¿s post-operative management which led to the worsening of symptoms and death.However, the relationship between the subject device and the event could not be determined since the source of the infection is unknown.This supplemental report includes a correction to d4 (model number is unknown).Also, information has been added to d8.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16525316
• MDR Text Key: 311099808
• Report Number: 9610595-2023-04126
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 04/18/2023
• Supplement Dates FDA Received: 05/04/2023
• 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
• Treatment: TREATMENT TOOL MODEL/SERIAL UNKNOWN
• Patient Outcome(s): Other; Death
• Patient Age: 80 YR
• Patient Sex: Male