MAUDE Adverse Event Report: COVIDIEN LP BRAVO PH CAPSULE DELIVERY DEVICE; ELECTRODE, PH, STOMACH

Model Number FGS-0313

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2020

Event Type  malfunction  

Event Description

Bravo capsule failed to deploy properly.Needed to calibrate and deploy a 2nd capsule which deployed successfully.States it is a diagnostic tool that is used to report the acid level in the esophagus and the capsules are a disposable piece.The medtronic rep said to report when the capsules do not deploy properly.

• Brand Name: BRAVO PH CAPSULE DELIVERY DEVICE
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12065829
• MDR Text Key: 258408944
• Report Number: 12065829
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 48065Q
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA