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

Model Number UHI-4

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The referenced uhi-4 was returned to olympus medical systems corp.(omsc) for evaluation.The evaluation could confirm the user¿s report, and found that the pressure sensor of the uhi-4 was damaged.Therefore the uhi-4 could not operate properly, and it caused the alarming and inoperability.The cause of the damage of the pressure sensor cannot be conclusively determined, however there was the possibility that the pressure sensor broke accidentally.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.

Event Description

Olympus was informed that before the laparoscopic cholecystectomy, the uhi-4 alerted and could not operate.The patient was already under anesthesia.The facility changed the referenced 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 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
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7040035
• MDR Text Key: 93499821
• Report Number: 8010047-2017-01800
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,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: No Information
• Device Model Number: UHI-4
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1