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

Model Number UHI-4

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The subject uhi-4 will not be returned for evaluation, and there is no further information available for the reported event.The exact cause of the reported event cannot be conclusively determined at this time.The uhi-4 instruction for use provides the following information: "intended use-this instrument is intended to insufflate the abdominal cavity, and provides automatic suction and smoke evacuation to facilitate laparoscopic observation, diagnosis and treatment.This instrument is intended for controlled co2 insufflation to create a cavity along the saphenous vein and/or radial artery to facilitate observation during an endoscopic vessel harvesting procedure.Warning: always use the uhi-4 as outlined in this instruction manual.Improper use will not only impair functions and prevent optimum performance, but may cause equipment damage and/or complications.Before each use, always inspect the equipment as outlined in this instruction manual." if additional information is received, this report will be supplemented accordingly.

Event Description

The physician reported that there was an intraoperative hemorrhage, which was not possible to locate the bleeding near the spleen, due to lack of exposure.It is not known at this time the patient outcome of if additional medical intervention was needed.

Manufacturer Narrative

This supplemental report is being submitted to report the additional information from the original equipment manufacturer (oem).The oem reported that since the device was not returned for evaluation the root cause for the reported event cannot be determined.However, it was determined that there was no shortage because we checked the items related to the indicated phenomenon in the attached document of the instruction manual.It is believed that the reported event was caused by the influence other than the equipment because we cannot confirm the defect in the actual product.Most likely user error.The customer reported " we checked the performance of the equipment at the site and confirmed that there was no problem.¿ as a result, the oem performed a dhr review and there was no abnormality found.

Manufacturer Narrative

This supplemental report is being submitted to report additional information.Additional information received from the user facility states that required intervention was necessary; however, the patient was not admitted to the hospital for an extended period.No gas leak test performed on the uhi-4 prior to the procedure.No lubricate was used on the equipment/hose connections.No alarms were noted.The gas cylinder was not confirmed to be closed prior to pressing the start switch.The obl team requested to sp product specialist to investigate the problem at the customer.He saw three procedures, in which the equipment did not present any problem.The equipment function in total capacity and did not presented any flaws.

• 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: 8969948
• MDR Text Key: 156803287
• Report Number: 8010047-2019-03215
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention