MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION HIGH FLOW INSUFFLATION UNIT; INSUFFLATOR

Model Number UHI-3

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2014

Event Type  malfunction  

Event Description

Olympus was informed that during the laparoscopic colectomy, the foot switch uhi-3 had not been able to operate.The facility had completed the procedure with use of the similar but other foot switch.There was no report of the pt's injury regarding this event.

Manufacturer Narrative

The referenced uhi-3 was not returned to olympus medical system corp (omsc) for evaluation, but the foot switch was returned to omsc.Omsc evaluated the foot switch and found that it had no abnormality and operated correctly.After the facility changed the foot switch into the other one, the uhi-3 operated correctly.Also the facility continued to use the uhi-3, therefore the uhi-3 had no malfunction.The exact cause of this phenomenon cannot be conclusively determined, however there is the possibility of this phenomenon is attributed to the user handling of the devices.There were no further details provided.If significant additional info is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4229897
• MDR Text Key: 4976354
• Report Number: 8010047-2014-00635
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/03/2014

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-3
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2014
• Initial Date FDA Received: 10/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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