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

Model Number FGS-0313

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem Dyspnea (1816)

Event Date 01/06/2020

Event Type  malfunction  

Event Description

The patient underwent an esophagogastroduodenoscopy (egd) with bravo capsule deployment.The patient developed a large amount of coughing before and after bravo capsule deployment.The bravo capsule came loose and came out.The bravo was not placed or attempted again.The egd was completed with no complications.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10074252
• MDR Text Key: 191558809
• Report Number: 10074252
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 47323Q
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Weight: 61