MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPE REPROCESSOR; ENDOSCOPE WASHER/DISINFECTOR

Model Number OER-PRO

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

The facility's bio-medical engineer reported that his olympus endoscope reprocessor was leaking detergent from the sensor.According to the initial reporter, there were no error codes present during this event.This event did not have any patient involvement.

Manufacturer Narrative

The biomed who called in this event is an olympus-trained engineer.He requested 3 new sensors to replace himself.He stated that he would replace the detergent and alcohol sensors and keep one as a spare.He also confirmed that there were no alcohol issues, he was simply proactively replacing the second sensor.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 based on the approved 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, it is likely that an external factor was applied to the detergent pipeline tube which could cause a crack allowing the detergent to leak.Since the device was not returned for evaluation, the definitive root cause of the detergent leak could not be determined.Per the legal manufacturer, the customer's event of the detergent leaking from the sensor has been determined that there is no potential for this malfunction to cause or contribute to an adverse event.

• Brand Name: ENDOSCOPE REPROCESSOR
• Type of Device: ENDOSCOPE WASHER/DISINFECTOR
• 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: 14620664
• MDR Text Key: 300896207
• Report Number: 8010047-2022-09549
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OER-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2018
• 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