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

Model Number	FGS-0450
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The bravo capsule appeared to have deployed.The physician rescoped the patient to see verify placement, and found that the bravo was not in position.Upon removal of the scope, the bravo was noted to be in the back of the patient's throat.

• Brand Name: BRAVO
• Common Device Name: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP
• MDR Report Key: 9437016
• Report Number: 9437016
• Device Sequence Number: 4202176
• Product Code: FFT
• UDI-Device Identifier: 07290101363064
• UDI-Public: (01)07290101363064
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/18/2019
• Report Date (Section F): 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FGS-0450
• Device Catalogue Number: FGS-0450
• Device Lot Number: 46580F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/18/2019