MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number GIF-H190

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

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Date 06/24/2022

Event Type  Death  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation (although it is anticipated to be). 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# 2429304-2022-00140. Customer reports 3 patients infected potentially related to one of two scopes; this scope or gif-1th190, sn: (b)(4).

Event Description

The customer reports three patients who underwent unspecified procedures using one of two different gastroscopes tested positive for a rare strain of antibiotic resistant e. Coli. The customer is unsure if the patients were cross infected with the scopes. Additional details regarding the patients and reported events have been requested. At this time, the only additional provided by the customer was that the scopes have been cultured by the facility. The cultures on both scopes have all come back negative, however, the scopes will be sent in for routine maintenance. Case with patient identifier (b)(6) reports patient one of three. Case with patient identifier (b)(6) reports patient two of three. Case with patient identifier (b)(6) reports patient three of three.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• 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: 15849114
• MDR Text Key: 304176120
• Report Number: 9610595-2022-04448
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/20/2022
• 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 Treatment Data

Date Received: 11/22/2022 Patient Sequence Number: 1