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

Model Number FGS-0636

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/09/2020

Event Type  malfunction  

Event Description

Device deployed but did not attach to mucosa.Detached probe was retrieved using a snare.No harm was done to patient.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 ME 02048
• MDR Report Key: 11071940
• MDR Text Key: 223813239
• Report Number: MW5098524
• 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: 12/22/2020

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: 01/19/2022
• Device Model Number: FGS-0636
• Device Catalogue Number: FGS-0636
• Device Lot Number: 50489F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2020
• 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: 79 YR