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

Model Number	BZ4212A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, 2-days post operatively, the patient was vomiting blood.The physician examined the patient and found no signs of active bleeding; also the tonsil beds looked good/normal and no blood clots could be seen.The physician is not sure where the bleeding came from.A suction bovie was used for the adenoidectomy but no other device was used in the tonsillectomy part of the procedure.The patient was seen by the doctor, but no surgical intervention was needed because the patient was not actively bleeding nor could a source of the bleeding be seen or determined at the time.Patient came in to be seen because of reported vomiting blood.

• Brand Name: BIZACT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8133634
• Report Number: 1717344-2018-01594
• Device Sequence Number: 11304111
• Product Code: GEI
• UDI-Device Identifier: 10884521723016
• UDI-Public: 10884521723016
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: BZ4212A
• Device Catalogue Number: BZ4212A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/05/2018
• 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: 6 YR