MAUDE Adverse Event Report: GIVEN IMAGING, INC BRAVO PH MONITORING RECEIVER; ELECTRODE, PH, STOMACH

Model Number FGS-0450

Device Problems Failure to Sense (1559); Calibration Problem (2890)

Patient Problem Insufficient Information (4580)

Event Date 11/18/2020

Event Type  malfunction  

Event Description

Defect in calibration of ph bravo capsules.During an upper gi endoscopy procedure, the attempt to place the ph bravo capsule in to the esophagus did not register with the bravo receiver.The capsule was not acknowledged and ph was not recorded after two attempts and procedure had to be discontinued.

• Brand Name: BRAVO PH MONITORING RECEIVER
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC ; 15 hampshire street ; mansfield MA 02048
• MDR Report Key: 10918753
• MDR Text Key: 218924940
• Report Number: MW5098120
• Device Sequence Number: 1
• Product Code: FFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR