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

Model Number OER-PRO

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

A fse was dispatched to the facility to evaluate the device.During the evaluation, the fse discovered that the air compressor was not running.He removed the panel and found a small cut in the detergent line.He noted detergent all throughout the machine and in the motor of the air compressor.The fse cleaned all the detergent in the machine, replaced the air compressor, and ran a reprocessing cycle to confirm no issues.The fse proceeded to run all electrical safety tests per the instructions for use (ifu), no errors were noted, the machine was in working order.If additional information becomes prior to the conclusion of the investigation, a supplemental report will be filed.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

Event Description

The customer called in to report that their olympus endoscope reprocessor was displaying multiple error codes and producing an electrical burning smell while reprocessing.A field service engineer (fse) was dispatched to the facility.During the evaluation, the fse removed the panel and discovered a small cut in the detergent line.This report is being submitted to capture the small cut noted in the detergent line.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: d8, g3, g6, h2, h6, and h10.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 legal manufacturer's investigation, it is likely that the tube got cracked by external factors because the edge holder of the tube was shifted.Then, detergent may have come into the cracks, causing chemical attack.This may have caused the tube to tear.The leaked detergent may have been dripped to the air compressor line which led to electrical short circuit.As a result, electrical burning smell may have occurred.Olympus will continue to monitor 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: 12636151
• MDR Text Key: 277169229
• Report Number: 8010047-2021-13164
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

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?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1