MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)

Model Number	MAJ-1985
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.Based on the results of the investigation, it is likely the event was caused by user handling (storage methods, replacement methods) because the o-ring is a consumable part and the central pins (which are parts intended to be removed) were missing.
Event or Problem Description
An olympus representative called in stating the customer had several maj-1985 cylinder hoses missing the o-ring and central pin.There was no consequence or impact to patients.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.Correction to g3 of the initial medwatch.The aware date should be 16-jun-2020.Olympus will continue to monitor the field performance of this device.

• Brand Name: CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX)
• Common Device Name: CYLINDER HOSE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11228840
• Report Number: 8010047-2021-01887
• Device Sequence Number: 14354204
• Product Code: HIF
• UDI-Device Identifier: 04953170324208
• UDI-Public: 04953170324208
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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-1985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2020
• Supplement Date Received by Manufacturer: 10/02/2022
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UHI-4
• Patient Sex: Unknown