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

Model Number UHI-3

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

The subject uhi-3 was not returned to olympus medical systems corp.(omsc).The uhi-3 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.The patient suffering from acute cholecystitis was sent to the department of surgery and anesthesia for laparoscopic cholecystectomy on (b)(6) 2018.The patient was combined with laparoscopy to provide video conditions and surgical space with pneumoperitoneum.The user set the set pressure of the subject uhi-3 for 13 mmhg.Under normal circumstances, the abdominal pressure will reach set value within 1 minute, but 3 minutes passed, the subject uhi-3 showed the abdominal pressure for 6 mmhg.After checking the pneumoperitoneum pipe joint, leakage had not been found.Because the abdominal pressure of the subject uhi-3 did not reach the set value, the field of vision was not enough and the surgical space was not enough during the operation.The user replaced the subject uhi-3 with an unspecified pneumoperitoneum device and the procedure was proceeded.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).The user did not provided further information about this event.The device history record was reviewed and found no irregularities.The exact cause of the reported event could not be conclusively determined.

• 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: 8498538
• MDR Text Key: 141455241
• Report Number: 8010047-2019-01629
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140297
• UDI-Public: 04953170140297
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR