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

Model Number	E2505-10FR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter, during procedure, a surgeon was burnt through the handle of this coagulator device.
Additional Manufacturer Narrative
Additional information: b3, 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.
Event or Problem Description
According to the reporter, during procedure, the surgeon's right thumb was burnt through the handle/tip of this coagulator device.
Additional Manufacturer Narrative
Additional information: d4 (udi#), d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted eschar build-up at the tip of the instrument.Damage to the insulation near the tip of the instrument.Functional testing found that the damage observed is consistent with misuse.It was reported that the surgeon's right thumb was burnt through the handle/tip of this coagulator device.The reported issue could not be confirmed.The product analysis noted evidence that the device was not used as intended.The evaluation detected an unreported condition: of insulation damage that has no relationship to the reported condition.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: contaminants may conduct electrical current resulting in patient or user injury.Wipe shaft to ensure that the outside of the suction tube remains free of fluids and mucus.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 MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CH 201114
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22012590
• Report Number: 3006451981-2025-00061
• Device Sequence Number: 7883575
• Product Code: GEI
• UDI-Device Identifier: 20884521038957
• UDI-Public: (01)20884521038957(17)290717(10)S24GE018
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2025

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 Model Number: E2505-10FR
• Device Catalogue Number: E2505-10FR
• Device Lot Number: S24GE018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 07/15/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/21/2025; 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2024
• 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