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

Model Number GIF-H180

Device Problem Microbial Contamination of Device (2303)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 10/16/2019

Event Type  Death  

Event Description

The manufacturer was informed that a patient reportedly expired and that the patient had creutzfeldt-jakob disease (cjd).The gi manager at the user facility further reported the scope had been used on other patients (not specified) but no other patient infections were reported from the use of this scope.The doctor performed a small bowel endoscopy with biopsy for mild esophagitis procedure on (b)(6) 2019.The patient's positive culture was detected on (b)(6) 2019.There was no scope malfunction reported.The scope was used with cold forceps.The scope was not cultured or sterilized since the date of the event.The scope was taken out of service at notification of patient's diagnosis, after being manual cleaned and high level disinfected.The gi manager also provided information regarding the reprocessing.Pre-cleaning is being performed immediately after a procedure as per manufacturer's pre-cleaning instructions.The scope is being brushed during manual cleaning.The scope is being leak tested.The effective concentration is being checked between each scope reprocessing.There are no issues with the aer.Flushing (air) into the channel of the scope is done after reprocessing.There have been no changes to the reprocessing personnel.The scope has been removed from service.

• Brand Name: EVIS EXERA II 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: 9366040
• MDR Text Key: 167762554
• Report Number: 2951238-2019-01197
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/31/2019,11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GIF-H180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/31/2019
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Weight: 112