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

Model Number FGS-0313

Device Problem Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2018

Event Type  malfunction  

Event Description

Bravo capsule failed to deploy during endoscopy procedure.Bravo procedure was repeated using another capsule and procedure was successful.

• Brand Name: BRAVO CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8939430
• MDR Text Key: 155809857
• Report Number: 8939430
• 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: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 42730Q
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA