MAUDE Adverse Event Report: COVIDIEN LLC / GIVEN IMAGING LTD. BRAVO; ELECTRODE, PH, STOMACH

Model Number FGS-0635

Device Problem Activation Problem (4042)

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

Event Date 03/18/2021

Event Type  malfunction  

Event Description

Device was unable to attach to esophageal mucosa despite visible suction pressure noted during deployment.Device was retrieved and no harm was done to patient.Fda safety report id# (b)(4).

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LLC / GIVEN IMAGING LTD.
• MDR Report Key: 11596197
• MDR Text Key: 243549621
• Report Number: MW5100431
• Device Sequence Number: 1
• Product Code: FFT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• Device Lot Number: 52097F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• 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: 90 YR