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

Model Number UHI-3

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2014

Event Type  malfunction  

Manufacturer Narrative

The referenced device was not returned to olympus medical systems corp (omsc) for eval, therefore omsc could not evaluate the referenced device.The facility continues to use the device, also the olympus service engineer confirmed that the device did not have any defect at the facility.Furthermore based upon the info from the facility, the nurse who had operated the device was novice and he/she had not understood how to operate the device.Therefore he/she could not detect that the abdominal pressure setting of the device was inappropriate.Consequently this phenomenon occurred.The mfg history was reviewed, with no irregularities noted.Based upon the finding of the eval, this report appears to be related to user handling.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.

Event Description

Olympus was informed that during the laparoscopic myomectomy, the uhi-3 had not been able to insufflate co2 into the pt's abdominal cavity.The facility had completed the procedure with use of the similar but other system.There was no report of the pt's injury regarding this event,.

• 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: 3877962
• MDR Text Key: 19453819
• Report Number: 8010047-2014-00242
• 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: 04/22/2014

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
• Device Catalogue Number: UHI-3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2014
• Initial Date FDA Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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