MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. OLYMPUS ENDOSCOPE REPROCESSOR

Model Number OER-3

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

As reported for this event by the customer, a doctor placed a scope used on a patient with creutzfeldt-jakob disease (cjd) in an irrigator.The scope was reprocessed in the device.Subsequently, there was a suspicion that unknown scopes were reprocessed in the said device.At this time, there is a suspicion that one such scope may have been used in a procedure for another patient.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 scopes impacted, and more.Customer has been advised to quarantine the devices until a definite diagnosis and clearance is obtained.This device is representing the one of the three devices that may have been used to reprocess the scope used on the patient with cjd.

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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, d4 and customer follow-up.B5: updated with information received from the customer.D4: added serial number.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¿s unawareness of handling of the devices which were used for a patient with creutzfeldt-jakob disease could have caused the user to clean the subject scope in the reprocessor.Correction: per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.The oer reprocessor was not used to clean the scope.Refer to patient identifier (b)(6) for scope used in the event.

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: OLYMPUS ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE REPROCESSOR
• 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: 15702213
• MDR Text Key: 307026284
• Report Number: 9610595-2022-03517
• Device Sequence Number: 1
• Product Code: FEB
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2018
• 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