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

Model Number OER-6

Device Problem Use of Device Problem (1670)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

Reports are being submitted on the oer-6 reprocessor and the scopes that were reprocessed using the oer-6.Please refer to the following reports: patient identifier of (b)(6) is related to model number: oer-6, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-1200n, serial number:(b)(4).Patient identifier of (b)(6) is related to model number: gif-h290z, serial number:(b)(4).Patient identifier of (b)(6) is related to model number: gif-q260, serial number:(b)(4).Patient identifier of (b)(6) is related to model number: pcf-h290zi, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: pcf-q260ai, serial number: (b)(4).Patient identifier of (b)(6) is related to model number: gif-h290z, serial number:(b)(4).Patient identifier of (b)(6) is related to model number: cf-q260ai, serial number: (b)(4).The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.There were no delays in the start of pre-cleaning after the scope was used and manual cleaning was done within one hour of use.The scopes did pass a leak test.The type of cleaning solution used for manual cleaning was unknown.The forceps channel, suction channel, air/water supply button, suction button, and forceps stopper were brushed.Manual disinfection was not done.The automatic endoscope reprocessor used was the oer-6.Aceside was used as the disinfectant and the type of detergent used was unknown.The disinfectant was not expired and was within the effective concentration range.The cleaning tube was connected to all channels of the scope during cleaning.The water filter was not replaced in the specified period.The products that treat rinse water, such as filters, were normal.The scopes were dried using the aer and they were stored in a cabinet without drying function.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

The customer reported the olympus endoscope reprocessor was operated with setting 2 and the process time was usually 22 minutes; however, recently, the process time was 29 minutes.After interviews at the site, the water filter was found to have last been replaced in (b)(6) 2021.The site had been instructed to replace the water filter, but the site was unable to replace it.The scopes were reprocessed and used on patients.The number of times the scopes were used on patients is unknown.There was no report of positive cultures.There was no reported patient harm or impact due to this event.

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.Based on the results of the investigation, the definitive root cause of the water filter issue could not be determined.It is possible that the event occurred due to the user's mishandling of the management method of replacing the water filter and that the unfulfillment of replacing the water filter may have caused the water filter to have clogged, which resulted in prolonged operation.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿chapter 7 routine maintenance: 7.3 replacing the water filter (maj-2317) replace the water filter periodically, at least once in two months to prevent contamination of the rinse water.¿ olympus will continue to monitor field performance for this device.

• 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 (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: 15832710
• MDR Text Key: 307897296
• Report Number: 9610595-2022-04338
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/14/2023

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: OER-6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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