MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO CF CAPSULE DELIVERY DEV; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problem Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

Attempted to place a bravo probe and device malfunctioned not allowing the bravo clip to be placed.Device was removed from patient without incident.Fda safety report id # (b)(4).

• Brand Name: BRAVO CF CAPSULE DELIVERY DEV
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC. ; mansfield MA 02048
• MDR Report Key: 10828915
• MDR Text Key: 216340734
• Report Number: MW5097776
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 50375F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR