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	Burn(s) (1757)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the device needs to test for normal operation.The patient had burns on the right side of the mouth.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product met specification as received.Visual inspection found no defects, except for a lot of eschar on the jaw plates and in the knife grooves.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.Pmv personal performed functional testing with the returned device.Visual inspection of the device found no defects.The device's jaw gap and electrical resistance were found to be within specification.The device was plugged into a test generator and was successfully recognized.The device was activated on simulated tissue ten times with satisfactory results.No alarms occurred during testing.The jaws opened and closed normally.The knife passed the cut test.There was a lot of eschar on jaw plate, and the device needs more frequent cleaning.The investigation found the device to function normally and within specifications.The instructions for use (ifu) also states, keep the instrument jaws clean.Build-up of eschar may reduce the seal and/or cutting effectiveness.Do not activate the instrument while cleaning.Wipe jaws surfaces and edges with a wet gauze pad as needed.If information is provided in the future, a supplemental report will be issued.

• 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: 9772706
• Report Number: 1717344-2020-00215
• Device Sequence Number: 2185796
• Product Code: GEI
• UDI-Device Identifier: 20884521723013
• UDI-Public: 20884521723013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/19/2024
• Device Model Number: BZ4212A
• Device Catalogue Number: BZ4212A
• Device Lot Number: 92330137X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Received by Manufacturer: 02/11/2020
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/01/2020
• Supplement Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1