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

Model Number FGS-0313

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2020

Event Type  malfunction  

Event Description

Pt undergoing esophagogastroduodenoscopy (egd) with bravo capsule insertion procedure.The first capsule failed to deploy, being stuck to the insertion device.A second capsule was calibrated and successfully inserted.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12066173
• MDR Text Key: 258326236
• Report Number: 12066173
• 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: 06/15/2021

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: 469490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA