MAUDE Adverse Event Report: GIVEN IMAGING INC. BRAVO CF CAPSULE DELIVERY, DEV, 1-PK; ELECTRODE, PH, STOMACH

Model Number FGS-0636

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 11/23/2021

Event Type  malfunction  

Event Description

Bravo calibration free reflux capsule delivery device did not deploy properly.Md had to break the holder in order to deploy the capsule.

• Brand Name: BRAVO CF CAPSULE DELIVERY, DEV, 1-PK
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.
• MDR Report Key: 12916938
• MDR Text Key: 281689607
• Report Number: MW5105729
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0636
• Device Lot Number: 54036F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Intersex
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White