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

Catalog Number FGS-0313

Device Problems Migration (4003); Activation Problem (4042)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/06/2021

Event Type  malfunction  

Event Description

During the procedure, bravo capsule inserted it, hooked it to suction for 45 seconds, and the unit did not deploy normally.Went away and went back down to look for the chip, we found that it was in the posterior pharynx.It was free-floating so anesthesia removed it with a mcgill forcep.We then had to recalibrate a new unit and after the appropriate recalibration sequence, patient was put back under anesthesia and the device was passed down to 34 cm connected to suction for 45 seconds.Bravo capsule was then placed successfully.Bravo capsule that malfunctioned was taken to risk management.Fda safety report id # (b)(4).

• Brand Name: BRAVO PH CAPSULE WITH DELIVERY SYSTEM
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.
• MDR Report Key: 11435160
• MDR Text Key: 238868484
• Report Number: MW5099824
• 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: Risk Manager
• 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: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2021
• Device Catalogue Number: FGS-0313
• Device Lot Number: 49851Q
• 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: 49 YR
• Patient Weight: 77