BRAVO FGS-0313

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for BRAVO FGS-0313 manufactured by Given Imaging.

Event Text Entries

[185024097] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9882476
• MDR Report Key: 9882476
• Date Received: 2020-03-26
• Date of Report: 2020-03-13
• Date of Event: 2020-03-11
• Report Date: 2020-03-13
• Date Reported to FDA: 2020-03-13
• Date Reported to Mfgr: 2020-03-26
• Date Added to Maude: 2020-03-26
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BRAVO
• Generic Name: ELECTRODE, PH, STOMACH
• Product Code: FFT
• Date Received: 2020-03-26
• Model Number: FGS-0313
• Catalog Number: FGS-0313
• Lot Number: 48063Q
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GIVEN IMAGING
• Manufacturer Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-26