MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER BIZACT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number BZ4212A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Swelling/ Edema (4577)

Event Date 04/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, post-operatively of tonsillectomy, the patient had severe swelling of the uvula.The patient had massive tonsillar hypertrophy and a small uvula.The lymphatic drainage was sealed off during used of the device resulting in uvular swelling.

• Brand Name: BIZACT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 11764344
• MDR Text Key: 248748313
• Report Number: 1717344-2021-00654
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521723016
• UDI-Public: 10884521723016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BZ4212A
• Device Catalogue Number: BZ4212A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/03/2021
• 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 Age: 35 YR