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

Model Number MAJ-590

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

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 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
• Type of Device: INSUFFLATION TUBE
• 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: 11053515
• MDR Text Key: 227202824
• Report Number: 8010047-2020-10805
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170061318
• UDI-Public: 04953170061318
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAJ-590
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1