MAUDE Adverse Event Report: COVIDIEN VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2100
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: e7507, e7507 polyhesive ii rem ret el w/cord (lot#51280279x); vlft10gen, vlft10gen ft series energy platformx1 (serial# (b)(6)).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
It was reported that during a tonsillectomy and adenoidectomy procedure, the cautery was not activating and was misfiring at the start of the case.All connections were checked by the circulator and scrub nurse.The surgeon was advised to check the cautery tip connection, and in response, removed and reinserted the tip.The patient underwent surgery, and once the davis-boyle gag was released, the surgeon identified significant partial to full-thickness burns to the bilateral corners of the patient¿s mouth that had occurred during the procedure.The surgeon immediately applied saline soaked gauze to the area.Plastic surgery was notified, and a staff came to the room to examine the area and will follow the patient.The plastic surgery team completed an assessment, took photographs, and recommended admission of the patient.The site was cleansed with sterile ns, dried, and polypore ointment was applied to the affected areas by the ent surgeon.The patient required additional anesthesia time.
Event or Problem Description
It was reported that during a tonsillectomy and adenoidectomy procedure, the cautery was not activating and misfiring at start of case.All connections checked by circulator, scrub nurse and surgeon told to check cautery tip connection.Surgeon removed and reinserted the tip as a response to this.Patient underwent surgery and once davis-boyle gag was released, surgeon identified significant partial to full thickness burns to the corners of the patient's mouth bilateral that had been caused during surgery.Surgeon immediately applied saline soaked gauze to the area.Plastic surgery was made aware and staff brought into room to examine the area and will follow patient.Patient had additional anesthesia time as the procedure was extended for 10 minutes, had plastic surgery consult to look at burns.Plastics came to the room, completed an assessment, took photographs and recommended admission of the patient twice more after to treat the burns under general anesthesia.Site cleansed with sterile ns, dried and polypore ointment applied to areas by ent surgeon.
Additional Manufacturer Narrative
Additional information: b5, g3 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the pencil was returned with a non-medtronic electrode inserted.Functional testing found the pencil had no visual defects and good button tactile.The switch resistance was in specification.The pencil did not self activate.The pencil button activation force was within the specification.The pencil functioned normally when activated in the generator.Good continuity observed.The electrode insertion/extraction was within the specification.It was reported that the device experienced difficult/intermittent activation and a device-related burn occurred.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: use of an incorrect electrode.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: use an appropriate covidien insulated electrode.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: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24413818
• Report Number: 1717344-2026-00274
• Device Sequence Number: 18792935
• Product Code: GEI
• UDI-Device Identifier: 20884524001590
• UDI-Public: (01)20884524001590(17)991231(10)91390002V
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup,Followup
• Report Date (Section B): 06/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E2100
• Device Catalogue Number: E2100
• Device Lot Number: 91390002V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 05/26/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/17/2026; 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2019
• 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: PLEASE SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown