MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SUCTION CLEANING ADAPTER

Model Number	MH-856
Medical Device Problem Code	Failure to Disinfect (1175)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is not yet available for this event.The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.
Event or Problem Description
As reported for this event by the customer, the device was cleaned but not sterilized before being used with another scope.There is no reported harm or adverse impact to any patient.
Additional Manufacturer Narrative
The device is not returned.As such, an actual device evaluation is not performed.An evaluation is done based on historical records and reported information.This supplemental report is being submitted to provide this information.Due diligence was executed for this event with no information, including initial reporter occupation, provided by the customer.The device history record review could not be performed nor manufacturing date available as the customer did not provide a serial number.The issue of the device being cleaned but not sterilized before being used with another scope is a finding of improper reprocessing, and not a device malfunction.There is no reported injury, infection or death associated with this event.The customer wanted to know what the effects of not sterilizing the device for use would be.The customer was advised of the necessity to follow the reprocessing steps of instructions for use (ifu) and provided the chart showing steps for sterilization and high level disinfection of the adapter.The ifu (reprocessing manual) cautions the user against insufficient reprocessing as below: 1.4 precautions: an insufficiently cleaned, disinfected or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them.·ifu (reprocessing manual) specifies steps from use to reprocessing, sterilization and storage in 4.4 workflow for manually cleaning and sterilizing endoscopes and accessories.

• Brand Name: SUCTION CLEANING ADAPTER
• Common Device Name: SUCTION CLEANING ADAPTER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12294050
• Report Number: 8010047-2021-09974
• Device Sequence Number: 3210457
• Product Code: FET
• UDI-Device Identifier: 04953170071270
• UDI-Public: 04953170071270
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2021

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
• Operator of Device: No Information
• Device Model Number: MH-856
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 09/03/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 09/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1