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

Model Number	CA15L2
Medical Device Problem Codes	Device Alarm System (1012); Leak/Splash (1354); Detachment of Device or Device Component (2907); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a renal tumor ablation procedure using the emprint needle, the ceramic tip of the ablation needle detached and remained within the renal mass.The procedure went fine and there were no issues.Simple insertion through a well-sized skin incision, no excess force whatsoever on the needle.Needle was inserted in real-time under ultrasound, the echogenic needle tip was clearly present at procedure start.At 8.20 minutes through a 10 minutes 150w cycle, the nurse noticed the fluid in the 500 cc bag was out, a second or two later the antenna alarm beeped and the cycle stopped.Connected a new bag and finished out the ablation.When smoothly removing the needle at procedure end, there was no tip and fluid was dripping from the tip.Computed tomography, which was part of the procedure, was performed to locate the retained needle tip and it was found in the deep margin of the tumor.A large amount of fluid was observed around the kidney as well.Although two lesions were initially planned for ablation, the surgeon chose to abort the procedure after the incident due to the significant fluid accumulation.The treatment for second lesion was rescheduled.The patient is currently doing well.
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.
Additional Manufacturer Narrative
Additional information: b6, d9, g3, h3, h6 correction: b1 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection revealed that the ceramic tip had detached from the device.The ceramic tip was not returned.The shaft was not cracked at the ceramic tip attachment point.The shaft was inspected under magnification, and adhesive residue was observed at the attachment point.The device was recognized when connected to a generator.It was reported that a component became disengaged, the device leaked, and an alarm was activated, resulting in a device-related aborted procedure.The reported issues were 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: EMPRINT
• 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: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22393063
• Report Number: 3006451981-2025-00073
• Device Sequence Number: 9160284
• Product Code: GEI
• UDI-Device Identifier: 10884521806542
• UDI-Public: (01)10884521806542(17)261118(10)S24LG009(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K163105
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: CA15L2
• Device Catalogue Number: CA15L2
• Device Lot Number: S24LG009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 09/06/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown