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

Model Number GIF-1TH190

Device Problem Device Reprocessing Problem (1091)

Patient Problems Sepsis (2067); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been received by olympus for evaluation.Device evaluation has not been initiated as of yet.Olympus is awaiting permission from the customer to send the scope to a third party testing lab for culture as a part of the investigation prior to physical evaluation.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.

Event Description

It is reported by the customer there was a positive culture test related to an evis exera iii gastrointestinal videoscope.It is also reported there is no patient or other person involved in this event.Additional details regarding the reported event have been requested.At this time, no additional information has been provided.

Manufacturer Narrative

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

Event Description

New information provided by the customer: we did not culture the scope.Our infection control group monitors blood stream infections (bsi) related to endoscopic ultrasound (eus) and endoscopic retrograde cholangiopancreatography (ercp) procedures, and a patient was positive for blood culture.The group was thinking that it was probably the bacteremia of the gastrointestinal (gi) pathogens and not scope related, but we wanted to ensure that everything was good with the scope.This customer reports 2 potential scopes related to patient the patient infection: case with patient identifier (b)(6) reports one scope.Case with patient identifier (b)(6) reports one scope.Follow-up information has been requested regarding the patient and reported event, at this time, no further information has been provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.Three attempts have been made to the customer for the cleaning, disinfection, and sterilization information, initial culture testing, and approval for third party culture testing with no response.If additional information becomes available, a supplemental report will be submitted.The device was evaluated where no abnormalities were found though there were several technical defects such as rubber cut, biopsy channel trace of scrapes, insufficient angulation, play on angulation control knob, cover deep scratches, lens small chip, lens cracked, rubber glue cracked, and scope-connector minor scratches.These defects were not considered severe enough to cause a potential adverse event and are likely due to wear and tear damage from use over an extended period of time.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, and the inability to gather additional information from the user, the relation between the event and the device could not be confirmed.Olympus will continue to monitor the field performance of this device.

• 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: 12330762
• MDR Text Key: 268320432
• Report Number: 8010047-2021-10329
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2020
• 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): Other