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

Model Number GIF-XZ1200

Device Problem Insufficient Information (3190)

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for 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

The customer reports there was an outbreak of extended spectrum beta-lactamase-resistant (esbl) bacteria at the hospital in patients who have undergone a procedure with a gastrointestinal videoscope (that had been reprocessed with an automatic scope reprocessor (aer)), per the physician in the infectious diseases department of the facility.The physician requested information regarding endoscope reprocessing methods and culture test methods in order to investigate the cause of the outbreak.It is unknown at this time if the outbreak is related to the scope.The field safety engineer (fse) staff has explained the culture method and reprocessing method to the facility.No scope culture results are available at this time.It is unknown how many patients are involved.It is unknown what treatment/intervention has been provided to the patients.The patients¿ current condition is unknown.This information has been requested and not yet provided.Case with patient identifier (b)(4) reports the scope case with patient identifier (b)(4) reports the automated scope reprocessor the scope has been reprocessed in.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, a relationship between the subject device and the event could not be identified.There was no detailed information provided by the facility regarding the infected patients.In addition, no details on the user¿s reprocessing methods were confirmed.Therefore, the root cause of this reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿if the instruments are not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective.Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope.¿ this supplemental report includes a correction to g2.Information added that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: 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: 15998698
• MDR Text Key: 305683540
• Report Number: 9610595-2022-05602
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

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-XZ1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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: OER-5
• Patient Outcome(s): Other