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

Model Number	FT0021S
Medical Device Problem Codes	Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574); Arcing (2583); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Electric Shock (2554); Superficial (First Degree) Burn (2685)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during cystodiathermy with rollerball via resectoscope, the device was working and then it stopped.The surgeon experienced electric shock when the device was used.Reattached and checked attachment at machine and the rollerball attachment was checked and ok.They tried to re-use rollerball, but white spark and heat came from cable.Cable was checked and looked frayed at site of insertion at handpiece, wires exposed and in half - new - was not like this as part of check.The surgeon was wearing surgical glove at time, black debris and break in glove that caused 1st degree burn to finger of surgeon.The burn was treated by giving medical first aid.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: FORCETRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19248560
• Report Number: 1717344-2024-01109
• Device Sequence Number: 17737551
• Product Code: GEI
• UDI-Device Identifier: 20884521062082
• UDI-Public: 20884521062082
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: FT0021S
• Device Catalogue Number: FT0021S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown