MAUDE Adverse Event Report: MEDTRONIC, INC. VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E3781R-28ASP
Medical Device Problem Codes	Peeled/Delaminated (1454); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: e3781r-28asp, lap curved spatula el retract (lot # 2009132x); e3781r-28asp, lap curved spatula el retract (lot # 2009132x).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 sparks occurred in the shaft part of all three during a robotic-assisted rectal resection, which was performed as a laparoscopic surgery with robot support.The event took place during vascular treatment with opti4.The electrodes were replaced, and the procedure continued with a fourth electrode, which functioned normally.The handle was not replaced and was discarded without being recognized as a defective product.No health damage occurred, and no additional interventions or procedures were required.Medtronic's initial evaluation of the incident found the devices had melting/burn damage near the aspiration holes.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found melting/burn damage near the aspiration holes.It was reported that arcing and sparking occurred.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.Build-up of eschar can become flammable, especially in oxygen enriched environments.Eschar build-up is common near the aspiration holes of the device.More frequent cleaning of device can prevent the fire hazard risk.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: tissue buildup (eschar) on the tip of an active electrode may create embers that pose a fire hazard, especially in oxygen-enriched e nvironments.Keep the electrode clean and free of all debris.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): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22770600
• Report Number: 2182208-2025-03926
• Device Sequence Number: 9120149
• Product Code: GEI
• UDI-Device Identifier: 10884521767805
• UDI-Public: (01)10884521767805(17)251130(10)2009132X
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K183594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2025

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 Expiration Date: 11/30/2025
• Device Model Number: E3781R-28ASP
• Device Catalogue Number: E3781R-28ASP
• Device Lot Number: 2009132X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown