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

Model Number OER-6

Device Problem Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the endoscope reprocessor water filters were replaced once every 2 years instead of once every 2 months, and the user facility staff irregularly disinfected the water supply pipes approximately once every 1-2 months after replacing the water filters.No patient infections or injuries reported.

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 two (2) years since the subject device was manufactured.The device not returned to olympus for inspection, therefore the customer's reportable malfunction could not be confirmed.Based on the results of the investigation, a definitive root cause could not be determined.However, although the facility staff had acknowledged the frequency of replacement of the water filter, they had managed replacement of the water filter not in accordance with description in the instrument manual but in accordance with the facility¿s own decision.As well the facility staff had acknowledged that disinfection of the water supply piping is required after replacement of the water filter.However, they had practiced disinfection of the water supply piping not in accordance with description in the instruction manual but practiced disinfection once in one or two months in accordance with the facility¿s own decision.Therefore, the subject event was caused by that they had managed equipment by judging that disinfection of the water supply piping after replacement of the water filter was unrequired.The event can be detected and prevented by following the instructions for use which state: instructions, operation manual for oer-6 section 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.Warning after replacing the water filter, be sure to perform the operation described in section 7.4, ¿disinfecting the water supply piping¿ to prevent multiplication of miscellaneous germs and staining inside the water supply pipes.Failure to perform this operation could result in contamination of the equipment piping and/or the scope, preventing effective reprocessing.Replace the water filter at least once in two months.Otherwise, miscellaneous germs and stains in the water may contaminate the equipment and/or the endoscopes and prevent effective reprocessing.Section 7.4 disinfecting the water supply piping disinfection of water supply piping is required in the following cases: before using this equipment for the first time (after installation of the water filter set) immediately after replacement of the water filter whenever bacteria are identified in the water supply piping before using the equipment when it has not been used for more than 14 days.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: 19017195
• MDR Text Key: 339252976
• Report Number: 9610595-2024-06835
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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: 03/29/2024
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2021
• 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