MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. ENDOSCOPIC CO2 REGULATION UNIT; INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE

Model Number OLYMPUS UCR

Device Problem Intermittent Continuity (1121)

Patient Problem No Information (3190)

Event Date 05/04/2018

Event Type  malfunction  

Event Description

Olympus co2 machine kept shutting off intermittently during colonoscopy procedure.Model: ucr, (b)(4).

• Brand Name: ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: INSUFFLATOR, AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA, INC.; 3500 corporate parkway; center valley PA 18034
• MDR Report Key: 7663396
• MDR Text Key: 113190916
• Report Number: 7663396
• Device Sequence Number: 1
• Product Code: FCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OLYMPUS UCR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 72