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

Model Number OER-PRO

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The endoscope service specialist (ess) observations include that the customer does not check the leakage tester before use and does not remove the scope completely from the water to disconnect the leakage tester.Some of the pre-cleaning steps are being omitted.The customer brushes while the suction is connected.The customer also needs care and handling in-services.The ess explained to the technician that the test strips must be used prior to every cycle that is run and that the machine should not be used until test strips are available.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

During a tiger team repair reduction, an endoscope service specialist (ess) noticed that the customer was not using test strips to check the mrc of the acecide-c.There was no patient involvement or injuries reported.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated.G4, g7, h2, h3, h4, h6, and h10.A review of the device history record confirmed the subject device was shipped in accordance to specifications.Based on the results of the investigation, the operator did not conduct the proper reprocessing procedure.The instructions for use identifies information regarding the suggested event within "chapter 3 inspection before use": 3.10 checking the disinfectant solution concentration level: prior to reprocessing, check the concentration of the disinfectant solution using a test strip to verify that the concentration of disinfectant solution meets the minimum recommended concentration.Replace the disinfectant solution when it fails to meet minimum recommended concentration or beyond the specified use life.Information was received from the customer via email on (b)(6) 2021 with the following information: they were last provided a reprocessing in-service on (b)(6) 2020, there has been no change in personnel since then and all personnel have been trained on how to properly reprocess an endoscope.They did not confirm that there were no patient infections, or scoped with positive cultures.

• 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: 11084202
• MDR Text Key: 227354036
• Report Number: 8010047-2020-11054
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

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 the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1