MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR

Model Number OER-5

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

The customer reported that his olympus endoscope reprocessor was experiencing a reprocessing issue.According to the initial reporter, when the staff removed the cleaning tube after cleaning the scope with the subject device, foreign material came out of the connector part.There was no patient involvement during this event.

Manufacturer Narrative

The device was returned.However, the device evaluation has not yet taken place and the investigation is still on-going.If additional information becomes available prior to the conclusion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide additional information.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation, possible causes may include the following: the foreign material in the actual device was a translucent, thin, elongated solid, elastic substance.As a result of organic qualitative analysis of foreign material, we found that it is silicon-based substance.After confirming the manufacturing process to investigate the cause, it was confirmed that some silicon-based sealants were used in the assembly work of the connector for connecting the cleaning tube of the endoscope reprocessor and the internal unit.However, due to the structure of the device, there is no possibility that the sealant will squeeze out or enter the water supply channel, and if there are any abnormalities, we confirmed that it can be detected during the inspection of the assembly process.Therefore, it was not possible to identify the causative substance of the foreign material or the intrusion route.There is a possibility that silicon-based foreign material has entered the water supply channel at some point, including when it is in use.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.

• Brand Name: ENDOSCOPE REPROCESSOR
• 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: 14022669
• MDR Text Key: 298229435
• Report Number: 8010047-2022-05788
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

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-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2021
• 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