MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION HIGH FLOW INSUFFLATION UNIT UHI-4

Model Number UHI-4

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2015

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus (olympus (b)(4) sales & service co.) for evaluation.Olympus confirmed the subject device worked properly.Olympus did not determine the cause of this phenomenon at that time because the phenomenon was not reproduced under the investigation.Olympus also checked the device history record of the subject device, and there was no irregularity found.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that during laparoscopic kidney tumor resection, the subject device could not supply co2 to the patient after the display of the subject device disappeared.The facility replaced the subject device to another device to complete the procedure.There was no report of patient injury in this event.

• Brand Name: HIGH FLOW INSUFFLATION UNIT UHI-4
• Type of Device: INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: kunimori yamaguchi ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5375615
• MDR Text Key: 36249073
• Report Number: 8010047-2016-00041
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/19/2016

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2015
• 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
• Patient Age: 59 YR