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

Model Number FGS-0313

Device Problems Defective Component (2292); Calibration Problem (2890)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  malfunction  

Event Description

When bravo ph capsule was opened for calibration, it was noted that the water reservoir was empty.The procedure had to be cancelled.Fda safety report id# (b)(4).

• Brand Name: BRAVO PH CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING; mansfield MA 02048
• MDR Report Key: 11422028
• MDR Text Key: 238415849
• Report Number: MW5099812
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 49352Q
• 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 Age: 76 YR