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

Model Number	FORCETRIADZE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	09/03/2018
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 patient got burn injuries while doing breast operation.
Additional Manufacturer Narrative
One device was received for evaluation.The returned sample met specification as received by medtronic.A visual inspection of the generator¿s exterior found no obvious issues.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORCE TRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7925663
• Report Number: 1717344-2018-01294
• Device Sequence Number: 11241270
• Product Code: GEI
• UDI-Device Identifier: 10884521133310
• UDI-Public: 10884521133310
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2018

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 Model Number: FORCETRIADZE
• Device Catalogue Number: FORCETRIADZE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Initial Date Received by Manufacturer: 09/11/2018
• Supplement Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1