MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS COOPERATION ENDOSCOPIC CO2 REGULATION UNIT UCR

Model Number UCR

Device Problems Leak/Splash (1354); Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 07/02/2015

Event Type  Injury  

Manufacturer Narrative

Olympus visited the facility for investigation.Olympus connected the subject ucr with a cylinder to reproduce the phenomenon, and confirmed that the subject device worked properly and the cylinder did not leak co2.Olympus could not determine the cause of this phenomenon because the phenomenon was not reproduced in the investigation.The cylinder valve might not be tightened perfectly before the facility disconnected the cylinder hose, so that the cylinder head might be frozen by co2 while leaked co2 was transformed from liquid into gas.In that time, the nurse got frostbite on her hands because she touched the frozen cylinder head when the cylinder was brought to outside the operating room.Olympus also checked the manufacturing history of the subject device, and there was no irregularity found.The instruction manual of this device already mentions cautions for the device and a cylinder handling.This report is being submitted as a medical device report in an abundance of caution.

Event Description

Olympus was informed that during colonoscopy, co2 in the cylinder ran out and the facility turned off the cylinder valve.The facility removed the cylinder hose connector from the cylinder, but co2 was filled in the operating room because co2 leaked from the cylinder.When the facility brought the cylinder to outside the operating room, the nurse got frostbite on her hands because she grabbed the cylinder head to lift it out.Her frostbitten hands were bandaged for healing.The facility completed the procedure to use air insufflation instead of co2.There was no report of patient injury in this event except her frostbite.Her frostbite was healed.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT UCR
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS COOPERATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 42 6425177
• MDR Report Key: 5043734
• MDR Text Key: 24650406
• Report Number: 8010047-2015-00786
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 08/03/2015

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: Physician
• Device Model Number: UCR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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
• Patient Outcome(s): Other