MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. HIGH FLOW INSUFFLATION UNIT

Model Number UHI-4

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

As the device has not yet been returned for evaluation, we are unable to determine a root cause for the reported event.If additional information becomes available or the device is returned for evaluation, a supplemental report will be filed.

Event Description

A biomed from a user facility reported that the front panel on the insufflation unit blanks out when he starts the gas flow.The issue occurred during preparation for a procedure.No patient harm or injuries were reported.No additional information has been obtained.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.Olympus did not receive the suspect device despite three attempts to do so with the customer.For this reason, the potential cause of the reported issue cannot be determined.Based on the legal manufacturer¿s investigation, the device history record (dhr) was reviewed and there were no problems found during the manufacturing of the device.The device met all specifications at the time of shipment.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10960507
• MDR Text Key: 226932398
• Report Number: 8010047-2020-09951
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/08/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1