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

Model Number FGS-0636

Device Problems Mechanics Altered (2984); Activation Failure (3270); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

When gastroenterologist attempted to attach bravo capsule to the esophagus following application of suction for 45 seconds, and holding down on the application button for 5 seconds, the capsule failed to deploy.Physician knew that following this process, the application button was then able to be returned to its pre-application position.This was not occurring, and as physician was pulling on application handle, the handle separated from the delivery system.Fda safety report id# (b)(4).

• Brand Name: BRAVO CF CAPSULE DELIVERY DEVICE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.; mansfield MA 02048
• MDR Report Key: 15362533
• MDR Text Key: 299371813
• Report Number: MW5111862
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2023
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 56238F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White