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

Model Number FGS-0450

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 11/13/2019

Event Type  malfunction  

Event 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
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP
• MDR Report Key: 9437016
• MDR Text Key: 169831257
• Report Number: 9437016
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101363064
• UDI-Public: (01)07290101363064
• 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: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• 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
• Device Lot Number: 46580F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA