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

Model Number GIF-H180

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

Patient Problem Death (1802)

Event Date 10/16/2019

Event Type  Death  

Manufacturer Narrative

The scope was not returned for evaluation.The gi manager 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.A review of the service history indicated the scope was purchased on june 13, 2012 with six repairs in the past three years; no repairs involving cross contamination issues and four repairs related to leaks in the scope.As part of the investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.The exact cause of the reported event cannot be determined.However, if additional information becomes available, this report will be updated accordingly.This reported event has been reported by the importer on mdr# 2951238-2019-01197.

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.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9375270
• MDR Text Key: 167980592
• Report Number: 8010047-2019-04083
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• 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?: No
• Date Manufacturer Received: 10/31/2019
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: AER:(2)CUSTOM ULTRASONICB00100, B00103; AER:CUSTOM ULTRASONIC SN (B)(4); AER:CUSTOM ULTRASONIC SN (B)(4); CLEANING DETERGENT: INTERCEPT; DISINFECTANT SOLUTION- MEDLINE OPA; LEAK TESTER: MEDIVATORS VERISCAN; SINGLE USE/DUAL END VALVE CHANNEL BRUSH:GI SOURCE.
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Weight: 112