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

Model Number	BZ4112-
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930)
Date of Event	05/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title: health related quality of life t-14 outcomes for pediatric bizact tonsillectomy source: medicina 2021, 57, 480 pp.1-8.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed between july 2016 and october 2019, a study evaluated pediatric patients (age 1-16) who underwent tonsillectomy using bizact.There were 146 patients and complications included: post-tonsillectomy hemorrhage and infection.Three patients required reoperation for bleeding and hospital admission was required for infection.

• Brand Name: BIZACT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12273585
• Report Number: 1717344-2021-01093
• Device Sequence Number: 2839773
• Product Code: GEI
• UDI-Device Identifier: 10884521552456
• UDI-Public: 10884521552456
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BZ4112-
• Device Catalogue Number: BZ4112-
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR