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

Model Number UHI-4

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced uhi-4 was not returned to olympus medical systems corp.(omsc) for evaluation at this time, therefore omsc could not evaluate the uhi-4.The uhi-4 was returned to olympus (b)(4).(b)(4) evaluated the uhi-4 and found that the uhi-4 did not start up when the uhi-4 was turned power on.(b)(4) exchanged the power unit of the uhi-4 to another power unit, the uhi-4 started up without any problem.The referenced uhi-4 is planned to return to omsc.There were no further details provided.The exact cause of the reported event could not be conclusively determined at this time.If additional information, this report will be supplemented.

Event Description

Olympus was informed that during the laparoscopic cholecystectomy, even though the facility turned on the uhi-4, the uhi-4 could not start.The facility changed the uhi-4 to the other unspecified similar device and the procedure was completed.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2018-00557 to provide the device evaluation results.The referenced uhi-4 was not returned to olympus medical systems corp.(omsc) for evaluation, however the power unit which had been assembled to the referenced uhi-4 was returned to omsc.Omsc evaluated the referenced power unit in combination with the uhi-4 owned by omsc and found that the front panel of the uhi-4 was not functioned correctly.Omsc returned the power unit to the manufacturer of the power unit for further investigation.There were no further details provided.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2018-00557 to provide the device evaluation results.The manufacturer of the power unit investigated the power unit and found that the capacitor for the power unit was damaged, consequently the power unit could not operate.Furthermore, the manufacturer of the capacitor concluded that the cause for the breakage of the capacitor was random failure.Omsc stated the counter measures against abnormalities of uhi-4 in the instruction manual of uhi-4.There were no further details provided.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: HIGH FLOW INSUFFLATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7387895
• MDR Text Key: 104426022
• Report Number: 8010047-2018-00557
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: PK110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/11/2019

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?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/02/2018
• Supplement Dates Manufacturer Received: 05/25/2018; 11/14/2018; 02/20/2019
• Supplement Dates FDA Received: 06/11/2018; 12/11/2018; 03/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1