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

Model Number TJF-Q190V

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 05/09/2016

Event Type  Death  

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.

• 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
• MDR Report Key: 16341458
• MDR Text Key: 309254085
• Report Number: 2429304-2023-00018
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/09/2023

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
• Distributor Facility Aware Date: 01/10/2023
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 82 KG