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 Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The high flow insufflation unit was not returned to the service center for evaluation.An investigation is ongoing to obtain additional information regarding the reported event.The cause of the reported event cannot be determined.Please reference related mfr.Report: 8010047-2019-03215 and 8010047-2019-03428 to account for the first and second case.

Event Description

The service center was informed that the user facility experienced intraoperative and postoperative complications with three cases due to the lack of a sufficient surgical field.An inadequate closure of the mesentery breach was noted with the third case, which caused an error in the closure that provoked the kinking of the enteral loop, culminating in an intestinal sub-occlusion that required a second surgery for correction.The patient¿s course of treatment and current condition is unknown.This report is 3 of 3 reports.

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 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: 9137837
• MDR Text Key: 160699232
• Report Number: 8010047-2019-03431
• 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

• 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
• Initial Date Manufacturer Received: 07/03/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 10/21/2019; 11/25/2019
• Supplement Dates FDA Received: 10/25/2019; 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention