MAUDE Adverse Event Report: GIVEN IMAGING, INC. BRAVO; ELECTRODE, PH, STOMACH

Lot Number 48438F

Device Problem Activation Problem (4042)

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

Event Date 03/06/2020

Event Type  malfunction  

Event Description

Physician appropriately deployed bravo but capsule was not released.Upon inspection of capsule, capsule was intact.Physician placed another capsule with second bravo.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9840532
• MDR Text Key: 183741265
• Report Number: 9840532
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 48438F
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 75