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

Model Number	FORCETRIADZE
Medical Device Problem Codes	Failure to Align (2522); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/11/2021
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 use, the unit had a rem/handpiece issue.The procure was delayed and the patient had a burn.
Event or Problem Description
According to the reporter, during excision of the breast, the unit had a rem/handpiece issue.The procure was delayed and the patient had a 1-1.5mm first degree burn at the left breast.The burn was caused by the heat from bovie tip.Bacitracin was used to treat the burn.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had a rem pin failure, a universal foot-pedal port (ufp) receptacle failure, a monopolar receptacle failure, a bipolar receptacle failure, and a device receptacle failure.Functional testing found that the rem port was very loose, causing the rem indicator to switch between red and green based on positioning of the connector.Found that the rem port pins were worn from repeat connections.It was also found that during the safety test the unit failed for leakage.Most of the front panel ports were defective thus causing the issue.It was reported that there was an adverse event without an identified device or use problem.Also, the device had an unknown rem issue.A potentially related device issue were confirmed.The most likely cause was traced to a component failure.The evaluation detected an unreported condition: the unit had a front panel failure.The most likely cause for the additional condition is traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORCE TRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12127297
• Report Number: 1717344-2021-00939
• Device Sequence Number: 14656914
• Product Code: GEI
• UDI-Device Identifier: 10884521133310
• UDI-Public: 10884521133310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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
• 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: 06/23/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Weight: 44