MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOSCOPIC CO7 REGULATION UNIT; CO2 REGULATION UNIT

Model Number UCR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/19/2016

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the device history record of the subject device, and there was no irregularity found.The ucr instruction manual states the corresponding method when there is an abnormality.There were no further details provided.If significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed the following information.Regarding an unspecified procedure, the patient complained of pain.The procedure was completed using the same device.There was no report of the prognosis of the patient.

Manufacturer Narrative

The subjected ucr was returned to olympus medical systems corp.(omsc) for evaluation.Omsc tried to reproduce the reported phenomenon, but the phenomenon could not be reproduced.Omsc confirmed the following things.There was no abnormality found at the insufflation operation of the subject ucr.There was no abnormality found at the insufflation operation of the subject ucr, after 4 hours working the subject ucr.There was no abnormality found at the insufflation operation of the subject ucr, when the vibration was applied to the subject ucr.There was no abnormality found at the inside of the subject ucr.The root cause of this event could not be conclusively determined, because the reported phenomenon was not reproduced.However, omsc was informed that the subject procedure was completed using the subject ucr.Therefore, omsc surmised that the cause of this event was the user handling of the devices or the malfunction of other devices, not the malfunction of the subject ucr.There were no further details provided.If significant additional information is received, this report will be supplemented.

• Brand Name: ENDOSCOPIC CO7 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6248480
• MDR Text Key: 65094416
• Report Number: 8010047-2017-00027
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK102763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

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: UCR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: 05/19/2017
• Supplement Dates FDA Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1