MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION HIGH FLOW INSUFFLATION UNIT; INSUFFLATOR

Model Number UHI-4

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem Injury (2348)

Event Date 04/28/2015

Event Type  Injury  

Event Description

Olympus was informed that at the beginning of a laparoscopic appendectomy procedure while the insufflation tube was inserted into the patient's abdomen, a burning smell was observed.The physician observed smoke coming from the insufflator and then the unit shut down.The patient was then taken to the operating room (or) for an open surgery as there were no spare insufflators at the user facility.The patient is reportedly in good condition after surgery.It was further reported by the user facility that the insufflator was inspected prior to use and no abnormalities were found.A biomed inspected the insufflator after the procedure and found that the insufflator failed due to a component failure caused by excessive heat.No further information has been provided.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The evaluation confirmed a burning smell when the top cover was removed during inspection.The device was not able to be powered on and a visual inspection found a burnt out fuse.The burnt out fuse was replaced with a similar one and that fuse immediately burned out when the device was powered on.The device became inoperative due to a faulty converter (power unit).A test converter was used and the device functioned properly and resumed its normal operation and passed all the functional inspection.There was fluid invasion found underneath the front chassis, traces of moisture on the rear panel, and on the top cover.The cause of the reported complaint is most likely due to the fluid invasion which could have shorted the circuit power unit and blown the fuses.The instruction manual warns user: "to prevent operator shock or instrument damage keep fluids away from all electrical equipment.If fluids are spilled on or into the high flow insufflation unit, stop operation of the unit immediately.".

• Brand Name: HIGH FLOW INSUFFLATION UNIT
• Type of Device: INSUFFLATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4786269
• MDR Text Key: 17336769
• Report Number: 2951238-2015-00234
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UHI-4
• Device Catalogue Number: UHI-4
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MODEL# WM-NP2 WITH SERIAL# (B)(4)
• Patient Outcome(s): Required Intervention