MAUDE Adverse Event Report: COVIDIEN LP BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0635

Device Problems Defective Device (2588); Activation Failure (3270)

Patient Problem Failure of Implant (1924)

Event Date 02/13/2023

Event Type  malfunction  

Event Description

Patient had a bravo¿ calibration-free reflux capsule with delivery system placed at an outpatient endoscopy facility.The study was determined to be a malfunctioning capsule.Doctor notified.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 16597607
• MDR Text Key: 312161124
• Report Number: 16597607
• Device Sequence Number: 1
• Product Code: FFT
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FGS-0635
• Device Lot Number: 58198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 03/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male