MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS OLYMPUS GF UC140P-AL5 TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number GF-UC140P-AL5

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Unspecified Infection (1930); Chills (2191)

Event Date 07/31/2015

Event Type  Injury  

Event Description

The patient had ercp and egd approximately one month ago; developed fever/chills 3 days later. Eus scope tested positive for cre. Unknown if patient was infected prior to egd or not.

• Brand Name: OLYMPUS GF UC140P-AL5
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate pkwy; center valley PA 18034
• MDR Report Key: 5090770
• MDR Text Key: 26270209
• Report Number: 5090770
• Device Sequence Number: 1
• Product Code: ITX
• 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

• Type of Report: Initial
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: GF-UC140P-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2015

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2015
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 09/21/2015 Patient Sequence Number: 1