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

Model Number	MH-856
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to the service center; therefore, no investigation was performed.In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer provided the following possible cause for the reported event is presumed as follows: the cause of the event was that the user did not recognize the necessity to clean the mh-856.The sales business center (sbc) already gave training to the user.The user now knows that they have to clean the mh-856.Also, the user did not clean the mh-856 as per description of ifu (reprocessing manual) of the endoscope.Description of ifu is as follows: manually cleaning the accessories: fill and press the syringe firmly against the connecting end of the suction cleaning adapter (mh-856) and flush the adapter with the detergent solution.Ensure that all air bubbles are expelled.
Event or Problem Description
The service center was informed that the customer needed clarification on the cleaning process of the suction cleaning adapter.The customer was using an alcohol flush to clean it.There was no patient involvement reported.

• 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: 11988571
• Report Number: 8010047-2021-07423
• Device Sequence Number: 3237402
• Product Code: FET
• UDI-Device Identifier: 04953170071270
• UDI-Public: 04953170071270
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2021

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
• Operator of Device: Other
• Device Model Number: MH-856
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 06/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1