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

Model Number FGS-0313

Device Problems Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Failure of Implant (1924)

Event Date 03/11/2020

Event Type  malfunction  

Event Description

Endoscopy placed a bravo ph capsule in a patient.The capsule calibrated normally and paired with endoscopy's monitor.However, when endoscopy tried to set the monitor to start recording it would no longer pair with the capsule.Endoscopy called customer support who had them test some different settings.It was determined that the capsule was not working.The physician spoke to the patient and explained the situation.Due to the risks of trying to remove the capsule that was placed, the patient did not want to attempt to have another one placed.The patient was going to follow up with the physician in his office, to see if this is necessary for her care and treatment, before the patient has another capsule placed.This is not the first time this has happened.List of issues endoscopy has had recently with some bravo ph capsules.Event1: device would not pair after capsule placed.Patient left.Lot # 47325q.Event2: when monitor was returned, it had 15 hours of unusable data that would not upload.Lot # 47765q.Event3: 53 hours of unusable data, that would not upload.Patient was rescheduled for next week.Lot # 47765q.Event4: 18 hours of unusable data, that would not upload.Lot # 47765q.Event5: device would not pair after capsule place.Lot # 48063q.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): GIVEN IMAGING; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9882476
• MDR Text Key: 185024097
• Report Number: 9882476
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/13/2020

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 Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 48063Q
• 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: 03/13/2020
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 9125 DA