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

Model Number	E4051-CT
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter during servicing at the facility, the inner blue parts of the devices were chipped/damaged after it had already been used and cleaned/sterilized.Photos was submitted showing the insulation was chipped off.There was no patient involved.
Additional Manufacturer Narrative
D10 concomitant products: e4051-ct, e4051-ct scovill-gr bay ins bip forc20cm (lot#:j2411201), e4051-ct, e4051-ct scovill-gr bay ins bip forc20cm (lot#:j1813801), e4051-ct, e4051-ct scovill-gr bay ins bip forc20cm (lot#:j1199201).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: d4 (udi#), 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 that the blue insulation by the tips of the forceps appears to be charred and melted.Functional testing found that without receiving the device, a detailed investigation could not be performed for the reported complaint.It was reported that during servicing at the facility, the inner blue parts of the devices were chipped/damaged after it had already been used and cleaned/sterilized.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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; 200 medtronic drive; lafayette,co
• Manufacturer (Section G): COVIDIEN; 200 medtronic drive; lafayette,co
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22804087
• Report Number: 3026612481-2025-00006
• Device Sequence Number: 9063358
• Product Code: GEI
• UDI-Device Identifier: 10884524000749
• UDI-Public: (01)10884524000749(11)231006(10)J2410401
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (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): 10/17/2025

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: E4051-CT
• Device Catalogue Number: E4051-CT
• Device Lot Number: J2410401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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