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

Model Number UHI-4

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2015

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-4 was not returned to olympus medical systems corp.(omsc).Omsc will investigate the subject uhi-4 to identify the root cause of this failure phenomenon when omsc receives it.The uhi-4 instruction manual states the corresponding method when there is an abnormality for the device.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

(b)(6) informed olympus (b)(4) of the event below on march 13th, 2019.On (b)(6) 2015, the subject uhi-4 was used for a laparoscopic partial nephrectomy procedure of the left kidney.During the procedure, the subject uhi-4 malfunctioned and the insufflation was stopped.The user replace the subject uhi-4 with an unspecified device and completed the procedure.There was no report of the patient¿s injury regarding this event.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc).Therefore, the exact cause of the reported event could not be conclusively determined.About this event, omsc already reported as mdr ref no.(b)(4).The inspection result with the subject device by olympus after this event, there was no abnormality.There was no history of repairs with the subject device.The device history record was reviewed and found no irregularities.Based on the evaluation result so far, it was surmised that the failure phenomenon was attributed to other than the subject device.

• 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: 8490467
• MDR Text Key: 141208864
• Report Number: 8010047-2019-01609
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UHI-4
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR