MAUDE Adverse Event Report: COVIDIEN EDGE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	E1455-6
Medical Device Problem Codes	Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: e1455, e1455 the edge ent/ima electrode x50 (lot#:251460284r), e1455, e1455 the edge ent/ima electrode x50 (lot#:251460284r), e1455, e1455 the edge ent/ima electrode x50 (lot#:251460284r.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 laparotomy, when the pencil was removed from the patient, plastic sheath on the insulated first electrode was missing.The procedure was delayed because theater staff were trying to locate plastic sheath.The second electrode's insulation on diathermy tip came off and could not be retrieved from the abdomen.Xray was not performed because the clear plastic piece on the insulated electrodes was not radio opaque and cannot de detected.Patient was closed without being able to locate the piece of plastic.Additional two electrodes from photo observation showing it was not used yet with claim from reporter that it was easily manipulated.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN; boulevard insurgentes 19030; tijuana,mx
• Manufacturer (Section G): COVIDIEN; boulevard insurgentes 19030; tijuana,mx
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23848291
• Report Number: 9610849-2025-00117
• Device Sequence Number: 9607352
• Product Code: GEI
• UDI-Device Identifier: 10884521713192
• UDI-Public: (01)10884521713192(17)280930(10)233030249R(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K955836
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2025

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: E1455-6
• Device Catalogue Number: E1455-6
• Device Lot Number: 233030249R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 10/30/2023
• 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: SEE H11.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown