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

Model Number	MAJ-590
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report for non-fatal serious injury/device malfunction has been stored under the covid-19 pandemic in accordance with the guidance published by fda, postmarketing adverse event reporting for medical products and dietary supplements during a pandemic.The device was not returned to olympus medical systems corp.(omsc), therefore omsc cannot investigate the device.The instruction manual provides the correct reprocess procedure of the device.Omsc concluded that this phenomenon is attributed to the inappropriate handling by the user.If additional information becomes available, this report will be supplemented.
Event or Problem Description
The device was not compatible with the low-temperature plasma sterilization system.However, the user reprocessed the device by low-temperature plasma sterilization system.There is a possibility that the device was used with insufficient reprocess.There was no report of patient injury associated with this event including the infection.The user facility did not provide other detailed information.

• Brand Name: INSUFFLATION TUBE
• Common Device Name: INSUFFLATION TUBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11053515
• Report Number: 8010047-2020-10805
• Device Sequence Number: 2602565
• Product Code: HIF
• UDI-Device Identifier: 04953170061318
• UDI-Public: 04953170061318
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K014166
• 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): 12/22/2020

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-590
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1