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

Model Number UHI-3

Device Problems Connection Problem (2900); Medical Gas Supply Problem (2985)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Manufacturer Narrative

The service center followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.The device was not returned to the service center for evaluation.The instruction manual states ¿ inspect the cylinder hose for uhi-3 for damage, cracks and other irregularities.Use the supplied wrench to attach the cylinder hose to the co2 gas inlet on the rear panel of the uhi-3.Tighten with a force of 24.5 n.M (2.5 kgf.M).¿.

Event Description

The service center was informed that during an unspecified procedure, after recently switching over from the type e-tank to the type h-tank gas cylinder, the gas cylinder hose failed.The hose was used with an insufflator.The user facility reported that the gas line was replaced with no further issue.It is unknown if the intended procedure was completed.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates.Additional information received from the user facility states that the device failed at the conclusion of a therapeutic laparoscopic cholecystectomy.No other devices were replaced during the procedure.There was no delay in the procedure.All of the connections were checked and found to be secure.The pressure was not too high, low or both.There was no damage to the insufflation tube.The needle had not yet been inserted.The gas cylinder was in the upright position.The settings were checked and were correct.The device was inspected.No damage or abnormalities were observed.The insufflator did not emit a warning.There was no error code.The valve on the gas cylinder was opened all of the way.The device will not be returned to olympus.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Please see the updates in sections: g4, g7, h2, h6 and h10.The legal manufacturer reviewed the contents of this complaint.The exact root cause of the reported event could not be determined.The legal manufacturer reported that the indication phenomenon is determined to have been caused due to failure in the high-pressure hose in light of the fact that no event pointed out occurred after the gas hose was replaced.The cause of damage to the high-pressure hose could not identified because the subject device was not returned.

• 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: 10451542
• MDR Text Key: 223648335
• Report Number: 8010047-2020-05821
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170140280
• UDI-Public: 04953170140280
• Combination Product (y/n): N
• PMA/PMN Number: K014166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

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: Health Professional
• Device Model Number: UHI-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/01/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/21/2020; 09/29/2020
• Supplement Dates FDA Received: 09/15/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1