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

Model Number UHI

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/09/2014

Event Type  malfunction  

Event Description

The subject device was used during a laparoscopic inguinal hernia repair.The user pierced trocars into the body of pt and prepared the endoscope.After the user powered the device, it suddenly powered off.The procedure was completed with other device.There was no pt injury reported.

Manufacturer Narrative

The subject device was not returned to olympus for eval.Therefore, olympus could not evaluate the subject device.From the serial number of the device, we know the device is a 20 year old product, and we no longer keep the mfg history of the device.The exact cause of this issue cannot be conclusively determined.But the user was using the device for more than eighteen years, so it is possible that the device was broken by aging degradation.There were no further details provided.If significant add'l 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: HIGH FLOW INSUFFLATION UNIT
• 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: 4379516
• MDR Text Key: 5238052
• Report Number: 8010047-2014-01151
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/09/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/1994
• 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