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

Model Number OER-PRO

Device Problem Restricted Flow rate (1248)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, of our investigation, the technical assistance center (tac) informed the customer that the oer-pro requires a minimum pressure of 14.5 psi to run the unit.Tac provided the customer with instruction on how to release the air from the internal water filter using the connector tube line.The customer was able to collected more than a gallon of water due the air pockets and stated the rinse cycle would not complete without error.It was determined that the 0.45 pre-filtration was also clogged.The filter was replaced in both machines and sufficient water pressure was noted.

Event Description

The service center was informed that the water pressure was at zero on two of the facility¿s oer-pro automatic endoscope reprocessors (aer).The user facility reported that the water had been shut off due to construction and now air pockets are in the water supply.There was no patient involvement reported.This 1 of 2 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide the legal manufacturer investigation results.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.The legal manufacturer confirmed the subject device was shipped in accordance with specifications via dhr.No similar complaint was confirmed from the user on the same defect, the same cause, and the same product.The lm reported that the most probable causes for the reported event are as follows: the suggested event may have occurred by the use of oer-pro in the following condition.Water supply at the user facility being on construction.Water pressure at the user facility was lower than the device required to be operated properly.Water filter being clogged.Therefore, the event was about the environment at the user facility.We could not confirm any factor to cause the event from design nor structure of the 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: 10853026
• MDR Text Key: 225931152
• Report Number: 8010047-2020-09022
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1