MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE SUCTION VALVE (STERILE)

Model Number	MAJ-209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility was unable to confirm suction valve model and believes it to be maj-209 or maj-207.Due the model/lot number being unknown no dhr review could be performed.The device was not returned to the service center for evaluation.The exact cause of the reported event cannot be determined.However, the most likely cause of the reported phenomenon was attributed to excessive force applied to the suction connector.
Event or Problem Description
The service center was informed that the suction valve broke off inside of the scope¿s channel during reprocessing.The user facility reported that the scope and the valve had previously been used in a procedure without issue.
Event or Problem Description
The procedure was a diagnostic endobronchial ultrasound (ebus).The user facility reported that there was no injury to the patient and the procedure was completed using the same device.The user facility stated that the problem occurred after the procedure was completed.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information related to the event provided by the user facility.Updates to sections b5 and b7.

• Brand Name: SINGLE USE SUCTION VALVE (STERILE)
• Common Device Name: SINGLE USE SUCTION VALVE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9729737
• Report Number: 8010047-2020-01451
• Device Sequence Number: 2927710
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

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
• Operator of Device: Health Professional
• Device Model Number: MAJ-209
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 03/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1