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 Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon return of the device, an evaluation will be performed, and a supplemental report will be submitted.
Event or Problem Description
The service center received a report of six single use suction valves (maj-209) all from the same lot number 8xh, that were breaking off either during or after an unspecified procedure.The six valves from lot 8xh were previously reported as part of a device recall, recall report number z-2148-2019, initiated on april 1, 2019.It is not known if the six valves reported, broke off before or after a procedure, or if the suction valves were used on one patient or multiple patients during one or multiple procedures.This is for the first suction valve that broke off out of the six valves reported.Report 1 of 6.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the initial device evaluation and correction of the lot number and manufacture date.Please see updated sections: d4, d10, h2, h3, h4, h6 and h10.The maj-209 single use suction valve was received at the service center for evaluation of broken suction valve connector.The received condition device confirmed the user facility¿s complaint.The visual inspection of the received condition maj-209 suction valve confirmed that one of the used valves had a break at the suction valve connector from the main body.The original equipment manufacturer (oem) has opened an investigation for this malfunction.A supplemental report will be submitted upon completion of the investigation.This is report 1 of 6.

• 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: 9660083
• Report Number: 8010047-2020-01075
• Device Sequence Number: 3654588
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K061313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: H8X03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2148-2019
• Patient Sequence Number: 1