MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III DUODENOVIDEOSCOPE; FLEXIBLE VIDEO DUODENOSCOPE, REUSABLE

Model Number TJF-Q190V

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

Patient Problem Unspecified Infection (1930)

Event Date 05/09/2016

Event Type  Death  

Manufacturer Narrative

A representative duodenoscope was chosen as the model/serial number were not reported.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.This report was submitted by the importer under the importer's report number: 2429304 - 2023 - 00018.

Event Description

A consumer reported to olympus that after the use of an unknown duodenoscope, the patient expired due to an infected scope.The patient initially had hip surgery after falling out of a car.A bone chipped and it was stated they used a scope at that time.It was reported that there was pus and the patient had to return several times to have the pus "removed." it was also stated that an olympus scope was used every instance he went to the hospital.At one point, the patient's closet in the hospital room was searched as it was reported that hospital staff were "looking for a scope." the patient was on neomycin but no specifics on treatment were available.The patient was taken to the recovery room on (b)(6) 2016 after an unspecified procedure and 5 minutes later a code blue occurred and the patient passed away.The cause of death was not reported.

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, since the device was not returned for an evaluation, and no additional event details could be obtained, a relationship between the subject scope and the reported event could not be identified.Therefore, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿operation manual; important information.Indications for use: tjf-q190v model scope is designed to be used for endoscopy and endoscopic surgery within the duodenum.¿precaution: do not use this endoscope for any purpose other than its indications for use.¿ olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: FLEXIBLE VIDEO DUODENOSCOPE, REUSABLE
• 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: 16341707
• MDR Text Key: 309251699
• Report Number: 9610595-2023-02153
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220587
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2023
• 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
• Patient Outcome(s): Required Intervention; Death; Hospitalization
• Patient Sex: Male
• Patient Weight: 82 KG