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

Model Number OER-PRO

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

The reported problem was resolved through an onsite service visit by an olympus field service engineer (fse).The fse confirmed the presence of a burning smell during an air compressor cycle while servicing the device.The fse replaced multiple parts to resolve the reported problem and a definitive root cause could not be determined.Following the fse's service on the device, the unit was tested and verified to meet electrical specifications and manufacturer's performance requirements.

Event Description

A user facility reported a burning smell when using the olympus oer-pro, endoscope reprocessor, then an "e21 air is not flushed through scope channels" error.There was no injury or harm, associated with the problem, reported to olympus.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and device history record (dhr) review.The dhr for the subject device was reviewed and it was verified the device was manufactured in accordance with documented specifications.The legal manufacturer performed an investigation.A conclusive root cause could not be identified.The legal manufacturer determined the following series of events likely occurred, resulting in the reported phenomenon: a crack in the detergent tubing near the detergent port caused detergent leakage in the device.The leaked detergent may have dropped on the harness of the compressor, which may have stopped the compressor from functioning normally.Moreover, the leaked detergent may have dropped on the harness of the compressor and led to a short-circuit, which may have caused the user reported burning smell.The crack in the detergent tubing may have occurred by some stress, however it is difficult to determine.

• 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: 10224545
• MDR Text Key: 223483071
• Report Number: 8010047-2020-03841
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2016
• 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