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

Model Number UNKNOWN

Device Problem Contamination (1120)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).There are five devices for this event captured in medwatches with patient identifiers (b)(6) as below: (b)(6) parent (gif-hq290) placeholder for suspicion that a scope used for a patient with cjd disease was used on another patient.(b)(6) child 1 (oer-3) device used to clean a scope used for patient with cjd disease.(b)(6) child 2 (oer-3) device used to clean a scope used for patient with cjd disease.(b)(6) child 3 (oer-3) device used to clean a scope used for patient with cjd disease.(b)(6) child 4 (unknown scope, representing the scopes processed in oer-3).Identity of the exact automatic endoscopy reprocessor (aer) oer-3 devices used is not known.Medwatch is submitted on all three oer-3 at the facility.This medwatch is for the patient identifier (b)(6).The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.This event is under investigation.A supplemental report will be submitted upon completion of the investigation or upon receiving additional information.

Event Description

As reported for this event by the customer, a doctor placed a device used on a patient with creutzfeldt-jakob disease (cjd) in an irrigator.The device was reprocessed in the automatic endoscopy reprocessor (aer).Subsequently, there was a suspicion that unknown devices were reprocessed in the said aer.There is no reported harm to any patient.The type of cjd of the patient, whether vcjd (mutant type) or scjd (sporadic type), is not known.More information will be available.The customer facility is conducting an investigation for all details surrounding this event, including cjd patient details, other patients impacted, total devices impacted, and more.Customer has been advised to quarantine the devices until a definite diagnosis and clearance is obtained.This device is representing the devices that may have been reprocessed in the aer in which the device used on cjd patient was reprocessed.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the updated legal manufacturer's final investigation and customer follow-up.B5: updated with information received from the customer.The cause as to why the scope was thought to have been used for a patient with the creutzfeldt-jakob disease could not be specified.However, the investigation was conducted by provided information as this event was not caused due to the failure in the actual device.The device history record (dhr) was unable to be reviewed for this device however, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The subject device was not returned for evaluation and the reported event could not be confirmed.Concerning the creutzfeldt-jakob disease, the following descriptions are described in the instruction manual.As a result, it was determined the suggested event can be prevented: ¿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.

Event Description

Upon further follow-up, it was confirmed the device was not contaminated and the tests results were negative for creutzfeldt jakob disease (cjd).

• Brand Name: UNKNOWN
• 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15702688
• MDR Text Key: 307008831
• Report Number: 9610595-2022-03518
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 01/16/2023
• Supplement Dates FDA Received: 02/06/2023
• 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 Sequence Number: 1