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

Model Number UHI-4

Device Problem Insufficient Information (3190)

Patient Problem Pulmonary Emphysema (1832)

Event Type  Injury  

Manufacturer Narrative

The referenced uhi-4 was not returned to olympus medical systems corp.(omsc) for evaluation, therefore omsc could not evaluate the uhi-4.In the hernia repair procedure, the facility stated that the causes of this phenomenon were attributed to the incorrect insertion of the surgical device into the patient, large patient and the prolonged procedure than usual.Also, the facility stated that the cause of this phenomenon was not attributed to the referenced uhi-4.The staff of olympus keymed(okm) visited the facility and checked the usage of the referenced uhi-4, they found that the facility did not confirm the setting pressure of the uhi-4 before the procedure, and used it with the setting pressure of the previous procedure despite the pressure setting should be set according to the type of the surgery.Furthermore, according to the literature, subcutaneous emphysema is known as common complication that while insufflation of an abdominal cavity.The reported phenomenon is thought of as common complication of abdominal insufflation with incorrect usage of the device.The uhi-4 instruction manual states the notice for the subcutaneous emphysema and appropriately handling of the device.Okm is scheduled to retrain the facility staffs.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is 2 of 3.

Event Description

Olympus was informed that since (b)(6) 2017, three patients suffered subcutaneous emphysema during the laparoscopic procedures.One case was the hernia repair, two cases were unspecified gynecological surgery.The patients required medical interventions.

Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2017-01300 to provide the device evaluation results.Okm informed omsc that the referenced uhi-4 had no abnormality and irregularity, however, prior to the procedure, the facility staff did not check the setting pressure of the uhi-4 required by the physician.Furthermore, okm informed omsc that the training to the facility staff had been completed.The serial number of the referenced uhi-4 was unknown, however omsc checked the manufacture histories of the all uhi-4 owned by the facility, there was no irregularity found.

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 ; 426425177
• MDR Report Key: 6847558
• MDR Text Key: 85091976
• Report Number: 8010047-2017-01300
• 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
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UHI-4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 01/31/2018; 02/20/2019
• Supplement Dates FDA Received: 02/09/2018; 03/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other