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

Model Number	FORCETRIADZE
Medical Device Problem Codes	Defective Alarm (1014); Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
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, external inspection found minor scratches on the cover.It was also noted that when the adapter was inserted and removed, occasionally the rem indicator would quickly flash from red to green back to red.This should not occur; the rem indicator should remain red until the correct impedance is seen.Traced issue down to a fault in the rem circuitry on the rf board.Unit will need the rf board replaced.There was no patient involvement.
Additional Manufacturer Narrative
Investigation summary one device was returned for evaluation.From the provided information, it is unknown if the device has or has not been used in the treatment or diagnosis of a patient.The returned sample did not meet specification as received by the manufacturer.External inspection found minor scratches on the cover.The service center reported that when the adapter was inserted and removed, occasionally the rem indicator would quickly flash from red to green back to red.The investigation isolated the failure to the rf board, but a root cause was not identified.The probable root cause could not be determined based on the information provided.The rf board was replaced to address the condition.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 IN 80301 3299
• MDR Report Key: 7252636
• Report Number: 3008361498-2018-00071
• Device Sequence Number: 140926
• Product Code: GEI
• UDI-Device Identifier: 10884521133310
• UDI-Public: 10884521133310
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K102913
• 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): 02/28/2018

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: 01/19/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1