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

Model Number GIF-H190

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2024

Event Type  malfunction  

Event Description

It was reported, a total of three endoscopes, two colonovideoscope's and one gastrointestinal videoscope were used on a 72-year-old patient who is subsequently under investigation for suspected creutzfeldt-jakob disease (cjd).The equipment has been in use since the procedural date on 37 additional patients.The initial intended procedures were therapeutic, gastroscopy and colonoscopy, and were completed using the same set of equipment.The device was inspected before the initial use.At this time, no health hazards have been reported and there are no reports of any confirmed patient infections from the endoscopes.

Manufacturer Narrative

The device was returned, and the evaluation found no additional reportable malfunctions other than those mentioned in b5.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction to g3 of the initial report, the date received by the manufacture was feb 19, 2024.This report is being supplemented to provide additional information based on follow-up with the user facility and the legal manufacture's final investigation.Additional details were obtained by follow-up with the user facility where: the district health board (dhb) determined to destroy the subject device.The device is no longer in circulation.The user facility declined to provide any additional details to olympus, opting to communicate directly with medsafe.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the user was not aware of suspicion of cjd when they used the device to the patient.Accordingly, the device may have been used to other patients after reprocessing."precautions prions, which are the pathogenic agents of the creutzfeldt-jakob disease (cjd) cannot be destroyed or inactivated by the reprocessing methods stated in this instruction manual.When using the endoscope and accessories on patients with cjd or variant creutzfeldt-jakob disease (vcjd), be sure to use them for such patients only, or immediately dispose of them after use in an appropriate manner to prevent the usage of exposed devices on other patients.For methods to handle cjd, follow the respective guidelines in your country." 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: 18870820
• MDR Text Key: 337626939
• Report Number: 9610595-2024-05092
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170305290
• UDI-Public: 04953170305290
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GIF-H190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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