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

Model Number	MAJ-209
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.The user facility was contacted for additional information and olympus was informed that the scope or suction valve will not be returned as there was nothing wrong with either device.The maj-209 does not fit the bronchoscope correctly which has been confirmed by other surgeons and staff.This was the first time this was an issue during a procedure.The maj-209 valve was used to finish the procedure.The surgeon just had to adjust the way the scope was held.This was inconvenient and not ideal.However, the procedure was able to be completed.The physician is experienced in using the scope.However, it is not known if other facilities use a different suction valve.If additional information is received, a summary will be provided in a supplemental report.
Event or Problem Description
The user facility reported that during a diagnostic bronchoscopy the suction valve fell out of the scope.After falling out of the scope, the valve could not be reinserted for proper function.Due to the valve issue, the medication could not be administered properly to the patient and as a result, the patient experienced some discomfort.The user facility did report that the intended procedure was completed with the same set of equipment.
Additional Manufacturer Narrative
This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation.As there was no part returned for investigation, a sample device was used to check connection to a test endoscope.No abnormalities were detected.A conclusive root cause for the reported problem could not be identified.As determined by the legal manufacturer, the reported connectivity issue is likely due to improper handling.

• 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: 10203973
• Report Number: 8010047-2020-03691
• Device Sequence Number: 2526877
• Product Code: EOQ
• UDI-Device Identifier: 14953170152426
• UDI-Public: 14953170152426
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: Other
• Device Model Number: MAJ-209
• Device Lot Number: 1100518
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR