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.

Event Description

Update: additional information provided by the customer: the patient underwent an esophagogastroduodenoscopy (egd) with biopsy for the indication of acute hemorrhagic anemia; active gastrointestinal bleeding on two dates, 59 days apart with two different gastroscopes.The infection was diagnosed by blood culture on 2 dates 28 days apart.The patient was treated with cefiderocol.The patient¿s current condition is reported to be deceased.Date and cause of death have been requested and not yet provided.Case with patient identifier (b)(6) reports patient three of three (1st scope used).Case with patient identifier (b)(6) reports patient three of three (2nd scope used).

Manufacturer Narrative

This report is being updated to report additional information provided by the customer.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the following non-reportable defects were observed: leakage from biopsy channel, switch button 1 (sw1) shifted, inner wall of biopsy channel scraped/cracked, insufficient angulation, play on up/down angulation control knob, insertion section sneaky at manipulation, objective lens (ob-lens) glue deteriorated, light guide (lg-lens) glue deteriorated, water invasion of 1 lens, bending section cover (a-rubber) glue discolored/cracked, universal cord under boot wrinkled, labeling at control section was wet, and inner control section/cover corroded.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, a root cause of the reported event could not be determined.The olympus endoscopy support specialist (ess) confirmed that after observing the customer's reprocessing steps of the device, there were no deviations from the instructions for use (ifu).The user also confirmed that after performing culture testing of the device, the results were negative.Therefore, a relationship between the reported patient infection and the subject device could not be identified.This supplemental report includes a correction to d9 to provide information that was inadvertently not included on the initial medwatch.An update has been made to h3.Also, additional information has been added to d8 and h4.Olympus will continue to monitor field performance for this device.

• 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,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/20/2022; 05/17/2023
• Supplement Dates FDA Received: 01/19/2023; 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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
• Patient Outcome(s): Death; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 57 KG