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

Model Number FGS-0636

Device Problems Mechanical Problem (1384); Premature Activation (1484)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2022

Event Type  malfunction  

Event Description

The patient came in to get a ph impedance study with digitrapper but after multiple failed attempts doctor agreed to use the bravo device instead because they can be placed under sedation rather than the patient having to be awake.She went back in for her second egd to place the bravo.Two bravo delivery devices had to be used during the procedure, both of them failed.Both deployment devices deployed before they were supposed to resulting in both bravo capsules migrating to the vocal cords.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13860309
• MDR Text Key: 287684890
• Report Number: 13860309
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 55103F
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Weight: 82 KG