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

Model Number UCR

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

Patient Problem Bowel Perforation (2668)

Event Date 07/19/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event could not be determined.Olympus made multiple follow ups by telephone and in writing in an attempt to obtain additional information regarding the reported event; however, no additional information was obtained.

Event Description

Olympus was informed that the patient's colon was perforated during a colonoscopy procedure.An olympus endoscope (model and serial number unknown) was also used in the procedure.It was also reported that the facility was using non olympus tubing, non olympus valves, and non olympus water bottle with the reported ucr machine.The patient's outcome is unknown.It is also unknown if the procedure was completed.No additional information was provided.This is report 3 of 4.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from fcx to hif.

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-516
• MDR Report Key: 5858165
• MDR Text Key: 51714879
• Report Number: 2951238-2016-00678
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK081173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/18/2019

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: UCR
• Device Catalogue Number: UCR
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2016
• Initial Date FDA Received: 08/09/2016
• Supplement Dates Manufacturer Received: 02/20/2019
• Supplement Dates FDA Received: 03/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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