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

Lot Number 49078F

Device Problems Therapeutic or Diagnostic Output Failure (3023); Physical Resistance/Sticking (4012)

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

Event Date 07/15/2020

Event Type  Injury  

Event Description

Bravo capsule deployed in esophagus but did not affix to esophageal wall.Capsule was seen in oral airway and observed entering through vocal cords per physician.Patient intubated by anesthesia and bronchoscopy performed where capsule was located and retrieved using a snare.Fda safety report id# (b)(4).

• Brand Name: BRAVO CF CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING LTD.
• MDR Report Key: 10301630
• MDR Text Key: 199880389
• Report Number: MW5095622
• 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: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 49078F
• Was Device Available for Evaluation?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 68 YR