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

Model Number GIF-1TH190

Device Problems Device Reprocessing Problem (1091); Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); Drug Resistant Bacterial Infection (4553)

Event Date 10/02/2020

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been returned to olympus for third party laboratory culturing and physical evaluation (after culturing and eto sterilization). The scope is currently with the third party laboratory undergoing culturing. The definitive cause of the user's experience cannot be determined at this time. The investigation is ongoing. This report will be updated upon completion of the investigation or upon receipt of additional relevant information. This event has been reported by the importer on mdr# 2951238 - 2021 - 00364.

Event Description

The customer reported after being notified by the state board of health, a cluster of six gastroenterology patients have been diagnosed with the same strain of carbapenemase-producing pseudomonas aeruginosa (cppa) during a six-month period. All six patients were found to have undergone procedures using the same evis exera iii gastrointestinal videoscope. Patient 1 of 6 is reported in case with patient identifier (b)(6). Patient 2 of 6 is reported in case with patient identifier (b)(6). (this report) patient 3 of 6 is reported in case with patient identifier (b)(6). Patient 4 of 6 is reported in case with patient identifier (b)(6). Patient 5 of 6 is reported in case with patient identifier (b)(6). Patient 6 of 6 is reported in case with patient identifier (b)(6). In this patient case: eight days after an endoscopic ultrasound (eus)/esophagogastroduodenoscopy (egd) with stent placement using an evis exera iii gastrointestinal videoscope, the patient had blood culture results showing: pseudomonas aeruginosa, carbapenem resistant (carbapenemase producer). The patient required unspecified treatment due to the infection. The indication for the procedure was malignant tumor of the head of pancreas, gastric outlet obstruction, duodenal stenting, and staging of malignant ascites. The patient¿s history was significant for: metastatic pancreatic adenocarcinoma, gastric outlet obstruction, diabetes mellitus (dm), and admission from hospice care for vancomycin resistant enterococcus (vre) bacteremia. The patient¿s current condition is reported as deceased. The patient¿s cause of death is not known to be associated with the device at this time. Cause of death has been requested, but not provided at the time of this report. The customer verified there was no malfunction of the olympus scope during the procedure. The customer reports after becoming aware of these events, the scope was immediately quarantined. The suspect scope was cultured, and all cultures were negative for pseudomonas aeruginosa. The customer also reports the suspect scope was carefully examined with no abnormalities noted. No breaches were found from standard high-level disinfection processes.

• Brand Name: EVIS EXERA III 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: 12180826
• MDR Text Key: 262208721
• Report Number: 8010047-2021-08963
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 07/16/2021 Patient Sequence Number: 1