MAUDE Adverse Event Report: COVIDIEN LP BARRX DAR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 64082

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Esophagus (2399)

Event Date 01/02/2012

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patient had a radio frequency ablation was ablated for barrett's esophagus and when the catheter was taken out, the electrode was helixed.An esophageal stent had to be inserted to allow healing of the perforated esophagus.Patient's treatment history were biopsies and no ablation.The endoscope was removed prior to the balloon catheter removal and the balloon was completely deflated prior to removal.The electrode was also properly wrapped before the inflation of the balloon.The perforation was confirmed through imaging.No other person was harmed or injured.

• Brand Name: DAR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer (Section G): COVIDIEN LP BARRX; covidien gi solutions; sunnyvale CA 94085 4022
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 9622821
• MDR Text Key: 189669751
• Report Number: 3004904811-2020-00001
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521211599
• UDI-Public: 10884521211599
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K142364
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/1999
• Device Model Number: 64082
• Device Catalogue Number: 64082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention