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

Model Number FGS-0312

Device Problems Failure To Adhere Or Bond (1031); Positioning Failure (1158); Calibration Problem (2890)

Patient Problem No Information (3190)

Event Date 06/14/2017

Event Type  malfunction  

Event Description

First bravo capsule failed to deploy and adhere to pt's esophagus during procedure, likely due to inadequate suction.A second capsule needed to be prepared and calibrated.This second capsule deployed properly.Disposable device malfunctioned.Procedure continued with another device.Technical error.The make of the equipment that failed is: given imaging bravo ph capsule delivery device.Ref # fgs-0312; id # phz- bravo 100.The actual device was discarded recently.They did keep it with the expectation that it would be needed by risk but after 2 months of not hearing anything they eventually discarded it.Therefore i do not have the lot # or id # for the device in question.

Manufacturer Narrative

The following elements have blank data.

Event Description

First bravo capsule failed to deploy and adhere to pt's esophagus during procedure, likely due to inadequate suction.A second capsule needed to be prepared and calibrated.This second capsule deployed properly.Disposable device malfunctioned.Procedure continued with another device.Technical error.The make of the equipment that failed is: given imaging bravo ph capsule delivery device.Ref # fgs-0312; id # phz- bravo 100.The actual device was discarded recently.They did keep it with the expectation that it would be needed by risk but after 2 months of not hearing anything they eventually discarded it.Therefore i do not have the lot # or id # for the device in question.

• Brand Name: BRAVO PH CAPSULE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 7005754
• MDR Text Key: 91229750
• Report Number: 7005754
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: FGS-0312
• Device Catalogue Number: PHZ- BRAVO 100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR