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

Model Number UHI-4

Device Problems Break (1069); Pressure Problem (3012)

Patient Problems Pain (1994); Caustic/Chemical Burns (2549)

Event Date 09/28/2021

Event Type  Injury  

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation and the investigation is in process.Concomitant medical products: maj-1080, unk serial;camera stack, processor, monitor, lights source.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Event Description

The customer reported to olympus the nurse suffered a cold burn to the palm of their hand during preparation for use before a procedure when the co2 gas escaped from the cylinder after the regulator 'flew off.' the customer noted the regulator was attached to the co2 cylinder at the start of the case in a semi-dark room and may have contributed to the incident.The nurse informed the olympus representative that after attaching the regulator to the co2 cylinder, there was a slight hissing sound of the gas escaping once the valve was opened.At that time, the nurse and another co-worker tried to close the valve but could not because the valve would not turn.The nurse proceeded to apply pressure to the regulator using his gloved hand in an attempt to slow or stop the leaking gas.The gas leakage continued to worsen while pressure was being applied until the regulator "flew off" the cylinder.After the regulator 'flew off' is when the nurse was burned by the escaping gas.After the regulator 'flew off,' the other team members were able to shut the valve off.The procedure was delayed less than five (5) minutes and was successfully completed using a similar device.No harm or injury to patient.Immediate treatment included placing his hand into warm water.The nurse was sent to the emergency room for further evaluation.The cold burn injury was diagnosed as a soft tissue injury and the nurse was instructed to stay home for two days.However, the nurse was absent from work for two (2) weeks due to the incident.The nurse reported the injury is improving but the soft tissue injury continues to cause issues which includes experiencing pain when moving his hand.Patient identifier (b)(6) is for uhi-4, high flow insufflation unit and nurse injury.Patient identifier (b)(6) is for maj-1080, cylinder hose and nurse injury.This is complaint 1 of 2 for patient identifier (b)(6) is for uhi-4, high flow insufflation unit and nurse injury.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.New information was added to the following sections: d8, g2, h4 and h6.The dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the o-ring (packing) of the high-pressure hose was damaged.It is possible the o-ring was broken and was caused by (b)(6); and the cylinder connecting part being cooled and touching the cooled part injured the nurse.As stated in the instructions for use, the event may have been prevented: 4.2 inspection of the cylinder hose for (b)(6).If the cylinder hose is damaged, replace it with a new one.If the packing is damaged, replace it with a new one or replace the cylinder hose with a new one.For information on how to replace the packing, refer to the leaflet "replacement procedure for packing (o-ring)" which is included with the cylinder hose for uhi-3 (b)(6) or the cylinder hose with switch over valve (pin) (b)(6).1.Inspect the cylinder hose for scratches, cracks, or other damage.2.Inspect the packing inside the yoke for scratches, cracks, or other damage.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12689314
• MDR Text Key: 278152340
• Report Number: 8010047-2021-13590
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04953170324147
• UDI-Public: 04953170324147
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K122180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2020
• 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: H10
• Patient Outcome(s): Other