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

Model Number	E2100
Medical Device Problem Codes	Unintended Power Up (1162); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: vlft10gen - vlft10gen ft series energy platformx1, lot# t3d62800dx 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.
Event or Problem Description
According to the reporter, during open procedure, one surgeon got an electric shock while leaning on a diathermy instrument (e2100) on top of a patient.The smoke evacuator had started, which refers to inadvertent button depression in diathermy instrument.In addition, the magnetic mat had a metal suction tip and diathermy on which the surgeon's hand rested.The devices were checked immediately after the procedure by a medical technician and no fault was found.The electrical plugs in the operating room were also checked, and no earth leakage has occurred - an earth leakage would have triggered an alarm.

• Brand Name: VALLEYLAB
• 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: 20707328
• Report Number: 1717344-2024-02104
• Device Sequence Number: 9903395
• Product Code: GEI
• UDI-Device Identifier: 20884524001590
• UDI-Public: 20884524001590
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K942183
• 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): 11/18/2024

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: E2100
• Device Catalogue Number: E2100
• Device Lot Number: 233380176R
• 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: 10/31/2024
• Initial Report FDA Received Date: 11/18/2024
• Date Device Manufactured: 12/04/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown