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

Model Number FGS-0313

Device Problem Failure to Advance (2524)

Patient Problem Blood Loss (2597)

Event Date 11/05/2019

Event Type  malfunction  

Event Description

Outpatient for endoscopic gastroduodenoscopy (egd) with bravo placement.First capsule, lot #469390, did not deploy after correct use of deployment by physician.A second bravo capsule calibrated and correctly placed by physician.Again, capsule did not deploy.Second capsule lot# 469390.Because the second capsule also did not deploy when removing wire, capsule dropped behind patient's tongue above vocal cords.Was retrieved with mcgrath visual and removed with mcgill forceps by doctor.Patient remained stable during procedure.Some bleeding of oral mucosa due to forceps use.No damage to teeth noted.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9563580
• MDR Text Key: 174149284
• Report Number: 9563580
• Device Sequence Number: 1
• Product Code: FFT
• UDI-Device Identifier: 07290101361688
• UDI-Public: (01)07290101361688
• 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: 12/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0313
• Device Catalogue Number: FGS-0313
• Device Lot Number: 46939Q
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2019
• Date Report to Manufacturer: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA
• Patient Weight: 95