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 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The referenced uhi-4 was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the uhi-4.The technician of (b)(4) confirmed the referenced uhi-4 and found that there was no abnormality and irregularity.The exact cause of this phenomenon cannot be conclusively determined at the current moment.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that before the laparoscopic cholecystectomy, the facility found that the pressure of the uhi-4 was abnormal.The patient was already under anesthesia.The facility changed the uhi-4 to the other 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 #8010047-2018-00829 to provide the device evaluation results.Omsc checked the device history record of the referenced uhi-4, there was no irregularity found.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 #8010047-2018-00829 to provide the device evaluation results.The referenced uhi-4 was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the uhi-4 and found that the uhi-4 could operate correctly for the setting value of the cavity pressure, however the volume indicator on the front panel of the uhi-4 displayed abnormal value.Furthermore, omsc checked the inside of the uhi-4 and found that the battery on the pc board was removed.Also, there was the damage due to impact on the exterior of the uhi-4.Omsc is continuously evaluating the uhi-4.There were no further details provided.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This is a supplemental report to provide additional information.It was confirmed there was rusty at the rear panel of the subject device.Olympus medical systems corp.(omsc) investigated the internal circuit board of the subject device and found a flow sensor had malfunction.Based on the investigation result so far, omsc determined that the failure phenomenon, which the pressure of the subject device was abnormal, was attributed to the malfunctioned flow sensor in the subject device.The exact cause of malfunction of the flow sensor could not be conclusively determined, however there is the possibility that malfunction of the flow sensor might be attributed to operating environment or external impacts due to inappropriate handling of the device by the user.The uhi-4 instruction manual states the appropriate handling and operating environment of the device.

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 192-8 507; JA 192-8507
• MDR Report Key: 7532488
• MDR Text Key: 109030339
• Report Number: 8010047-2018-00829
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1