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

Model Number UHI-4

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2016

Event Type  malfunction  

Manufacturer Narrative

The subjected device was returned to the service department of the overseas subsidiary of olympus for evaluation.This service department tried to reproduce the phenomenon, and the phenomenon was reproduced.This service department evaluated the device, and found the following.There was stain like oil inside the tube connecting to the electropneumatic-proportional-control-valve.This service department replaced the installed electropneumatic-proportional-control-valve with a new electropneumatic-proportional-control-valve, and the phenomenon was resolved.The electropneumatic-proportional-control-valve was returned to olympus medical systems corp.(omsc).Omsc tried to reproduce the phenomenon, and the phenomenon was reproduced.Omsc evaluated the electropneumatic-proportional-control-valve, and found the following.There was black dirt inside the pipeline.Omsc checked the device history record of the subject device, and there was no irregularity found.Omsc requested the evaluation to the manufacturer of the electropneumatic-proportional-control-valve.The manufacturer of the electropneumatic-proportional-control-valve evaluated the electropneumatic-proportional-control-valve, and reported the following to omsc.There was dirt on the air outlet.Air was not sent properly.There was a large amount of oil inside the unit, and there were foreign materials on the diaphragm.There were the large amount of oil and foreign materials inside the unit, so the malfunction of each parts of the electropneumatic-proportional-control-valve occurred.As a result, the subject phenomenon occurred.The manufacturer conducted the analysis of component about the oil and the foreign materials detected from inside the unit.The oil and the foreign materials were not caused by the parts and the manufacturing process.So there was a high possibility that these foreign materials have got into the unit from the outside.The uhi-4 instruction manual states the corresponding method when there is an abnormality.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

On (b)(6) 2016, olympus was informed the following information.During an unspecified procedure, the user facility set the flow rate mode to "high" or "middle", and insufflated.When the flow rate exceeded 12l/min, the insufflation stopped.As a result of the additional research, olympus was informed the following information on (b)(6) 2016.The intended procedure was the laparoscopic surgery.The user facility replaced the subject device with the insufflation unit made by stryker, and completed the procedure.There was no report of the patient's injury regarding this event.

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 6091628
• MDR Text Key: 59560451
• Report Number: 8010047-2016-01407
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/10/2016

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: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2015
• 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