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

Model Number FGS-0636

Device Problems Entrapment of Device (1212); Unintended Movement (3026)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/23/2021

Event Type  malfunction  

Event Description

Suction confirmed >550 mmhg by doctor during placement of the bravo¿ calibration-free reflux testing system.The bravo package was opened, all pieces intact, and trocar not visible in window.The bravo delivery system was placed inside the esophagus of the patient, and confirmed with endoscope.Suction was applied and when 550 mmhg were reached, a 30 sec countdown started.Doctor removed white piece, turned knob and suction, and held for additional 5 seconds.Endoscope reinserted to ensure placement of bravo¿ calibration-free reflux capsule.However, doctor could not see the capsule in the esophagus or stomach.X-ray confirmed it loose in the small intestine.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11744394
• MDR Text Key: 247920320
• Report Number: 11744394
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101369714
• UDI-Public: (01)07290101369714
• 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: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• 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: 51422F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA