MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; CAMERA, STILL, SURGICAL

Model Number RFB-0450

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

Main suspect: was problem with transmit of the capsule.The bravo recorder found serviceable and in compliance to requirements.

Event Description

According to the reporter, the bravo recorder was waiting for the capsule after it was calibrated and placed.The led light is red.Technical support had customer turn off the recorder and restart the study and it did not pick up the capsule.Technical support had the customer hold the power button down to reset and it continued to fail.The device is under warranty and will be replaced.The device was returned for investigation.The investigation was done and it was determined that the main suspect was the problem with transmitting of the capsule and the recorder was serviceable and the failure could not be reproduced.There was no patient or user harm due to the alleged device malfunction, but a repeat procedure was performed.

• Brand Name: BRAVO
• Type of Device: CAMERA, STILL, SURGICAL
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: sharon murphy ; 15 hampshire street; mansfield, MA 02048 ; 2034925297
• MDR Report Key: 7199167
• MDR Text Key: 97669893
• Report Number: 9710107-2018-00114
• Device Sequence Number: 1
• Product Code: FTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RFB-0450
• Device Catalogue Number: RFB-0450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2016
• Date Manufacturer Received: 07/22/2016
• 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