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

Model Number OER-PRO

Device Problem Material Disintegration (1177)

Patient Problem No Patient Involvement (2645)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

The device was inspected and repaired by an olympus field service engineer (fse).The fse confirmed the user report of black particles.The fse replaced the required tubes and the device passed the required maintenance tests.This event is under investigation.A supplemental report will be submitted upon receiving additional information.

Event Description

It was reported there was black particles recurrence in the endoscope reprocessor during reprocessing.As reported, there was no patient involvement in this event or impact to patient care.

Manufacturer Narrative

This follow up report is submitted to provide the results of the legal manufacturer's investigation, including a device history record (dhr) review.We confirmed via dhr review that the subject equipment was shipped in accordance with specifications.As the actual item was not available and the material of the object unknown, we cannot conclusively specify the cause of the reported event.Probable cause for the reported issue, black particles in basin, is the hose in the subject equipment has peeled off, as fine particles, due to deterioration from long time use.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
• MDR Report Key: 11372764
• MDR Text Key: 233361421
• Report Number: 8010047-2021-02955
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 04953170258589
• UDI-Public: 04953170258589
• Combination Product (y/n): N
• PMA/PMN Number: K103264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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-PRO
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1