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

Model Number FGS-0635

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 06/02/2021

Event Type  Injury  

Event Description

We tried to place a bravo/esophageal ph monitor, it suctions to the esophageal wall, the device was setup and ready to go.The gi doctor performing the procedure placed the monitor with the delivery device, turned the suction on for 30 seconds as directed and deployed it.On recheck with the endoscope the bravo monitor had not attached properly to the esophageal wall, it was near the vocal cords.The device was setup correctly and seemed to be no user/operational errors to my knowledge, the monitor/delivery device could possibly defective or the suction equipment was not in proper working condition.The delivery device could've not been close enough to the esophagus wall or moved away from it somehow before suction was turned on.It resulted in the patient having an emergent bronchoscopy done to remove the ph monitor from one of her lungs which was done successfully.Suction was checked prior to use.This is the 3rd case i am told where this has occurred.We have another one scheduled monday and will see if the rep can come check the machine.Device/delivery system and packaging not saved.

• Brand Name: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12106554
• MDR Text Key: 259614805
• Report Number: 12106554
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-0635
• Device Catalogue Number: FGS-0635
• 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: 06/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 15330 DA
• Patient Weight: 106