MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. EVIS EXTRA II; GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number GIF-H180J

Device Problem Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2016

Event Type  malfunction  

Event Description

"tip metal is getting too hot.".

• Brand Name: EVIS EXTRA II
• Type of Device: GASTROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS AMERICA, INC.; 2400 ringwood avenue; san jose CA 95131
• MDR Report Key: 5652272
• MDR Text Key: 45096003
• Report Number: 5652272
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GIF-H180J
• Device Lot Number: 2205488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2016
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1