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

Model Number	MAJ-1971
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Olympus medical systems corp.(omsc) investigated the device and could confirm the reported phenomenon.As a result of analyzing the components, omsc found that the main component of the white material was polyoxymethylene (polyacetal).Polyoxymethylene (polyacetal) is used for the cleaning tank of the oer-4 or a mouthpiece.The exact cause of the reported event could not be conclusively determined.However, omsc surmised that a piece of the mouthpiece or the cleaning tank got into the tube of maj-1971.If additional information becomes available, this report will be supplemented.
Event or Problem Description
During the preparation for use, the user found that there was a white foreign material in the tube of the product.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.

• 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: 10761392
• Report Number: 8010047-2020-08325
• Device Sequence Number: 19644932
• Product Code: FEB
• UDI-Device Identifier: 04953170329623
• UDI-Public: 04953170329623
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 10/30/2020

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: No Information
• Device Model Number: MAJ-1971
• Device Lot Number: ¿¿
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1