MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. CONNECTING TUBE

Model Number	MAJ-1971
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation.Therefore, the cause of the reported event cannot be conclusively determined.The issue will be resolved by replacing the maj-1971.
Event or Problem Description
It was reported that during reprocessing the plastic connector on the scope washer accessory cable was found to be broken.No harm was caused by this issue and the broken connector was not used once it was found the tab was broken.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information to mdr# 8010047-2020-03027.The original equipment manufacturer (oem) could not perform a device history record review as no serial number was provided for the subject device.As part of the investigation, olympus followed up with the user facility t obtain additional information regarding the event but with no results.However, based on the information received the oem completed the investigation and determined the potential cause of the suggested event might be the lid of oer-pro was closed while maj-1971 was in between the lid and the reprocessing basin, maj-1971 and endoscopes being hit massively.Since there was no additional information from the user, we could not confirm any factor to cause the event from design nor structure of the device.Olympus will continue to monitor the field performance of this device.The instructions manual provides the following - preparation and inspection - visually inspect the connecting tube to ensure that are no cracks, breaks, rips, scratches attached debris or other irregularities.

• Brand Name: CONNECTING TUBE
• Common Device Name: CONNECTING TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10105960
• Report Number: 8010047-2020-03027
• Device Sequence Number: 947526
• Product Code: FEB
• UDI-Device Identifier: 04953170329623
• UDI-Public: 04953170329623
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103264
• 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): 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: Health Professional
• Device Model Number: MAJ-1971
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 06/01/2020
• 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