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

Model Number	E3781R-28ASP
Medical Device Problem Codes	Arcing (2583); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the outer black insulation was melted and slightly deformed at the aspiration holes.The tip broke off and was returned.The electrode had a lot of eschar.Functionally, a hipot test on the sample was performed and all of the test results were within specification.Tissue remained in the sheath side hole on the tip of the electrode.When eschar or tissue is stuck in the sheath side hole, there is a risk of arcing.It was reported that the device had arcing/sparking and the device broke during application.The reported issues were confirmed.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: 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 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.
Event or Problem Description
According to the reporter, during a laparoscopic surgery, the device generated a lot of sparks when used in the abdominal cavity app roximately 5 hours after the start of the surgery.It was believed that the problem was caused by the burning of the eschar, but even after the tip was cleaned, the sparks seemed to be coming from part of the tube, attempt to find the right time to replace the device with another product of the same model number was urged and the tip got damaged, the damaged part was shaking and detached, it was grasped with a forceps and removed from the abdominal cavity.No x-ray was performed to locate and/or retrieve the broken piece.There was no patient injury.

• 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: 19191473
• Report Number: 1717344-2024-01065
• Device Sequence Number: 20950888
• Product Code: GEI
• UDI-Device Identifier: 10884521767805
• UDI-Public: 10884521767805
• 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
• Report Date (Section B): 04/26/2024

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 Expiration Date: 10/31/2025
• Device Model Number: E3781R-28ASP
• Device Catalogue Number: E3781R-28ASP
• Device Lot Number: 2008072X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/26/2024
• 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
• Patient Sex: Unknown