MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OER-4 100V; ENDOSCOPE REPROCESSOR

Model Number OER-4

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/21/2021

Event Type  malfunction  

Event Description

Olympus medical systems corp.(omsc) was informed from the user that after the reprocess, the phenomena that black residue had remained on the circulation port mesh filter in the reprocessing basin of the subject device occurred three times on (b)(6) 2021.No abnormality was found on the tank hose in the disinfectant solution tank, and the cause was unknown.The field service engineer requested to the user that checking the circulation port filter every time before use and cleaning the circulation port filter with running water if black residue existing.It was found that the reported phenomena occurred in the rinsing process, therefore the field service engineer replaced the water supply valve, the channel pump, the flow pump, and so on to new ones in three steps on-site.The reprocessed endoscopes using the subject device were used for the procedures, but no health hazard of the patient was reported.This report is three of three ((b)(6) 2021).

Manufacturer Narrative

The device has not been returned to olympus yet.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The suspect device has been returned to olympus for evaluation and confirmed the event.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, there was a dried black foreign material in the pump.The foreign material is likely to be a mixture of cellulose and protein according to the component analysis.It¿s likely that the dirt adhering to the scope accumulated in the channel due to insufficient pre-cleaning before reprocessing with the reprocessor, as a result, it dried and became black foreign material and it discharged to the washing tank.The event can be prevented by following the instructions for use which state: ¿it is necessary to pre-clean the endoscope before cleaning the endoscope with this device.Immediately after the end of procedure, follow the reprocessing procedures described in the endoscope's "attachment" and "operation manual", at least from bedside cleaning to the outer surface cleaning of the main cleaning, and around the forceps elevator, brush the suction channel and even clean the buttons.If the device is operated with a large amount of dirt adhering to the endoscope without pre-cleaning, the reprocessing of the endoscope will be insufficient, or dirt will accumulate inside the device and could interfere with the operation of the device.¿ olympus will continue to monitor field performance for this device.

• Brand Name: OER-4 100V
• Type of Device: ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13422767
• MDR Text Key: 295971628
• Report Number: 8010047-2022-02286
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2019
• 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