MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EMPRINT SX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	CABK8666L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, during an ablation procedure, the sensor was attached to the non-medtronic probe and everything went fine.However, when removing the probe/tracker a small white piece of plastic appeared on the liver.This was a laparoscopic case, so able to see it clearly and removed it and everything was fine.Doctor said he did not apply strong force, but port was narrow and he did acknowledge the small fit of it.Patient was very large.There was no patient injury.
Event or Problem Description
According to the reporter, during an ablation procedure, the sensor was attached to the non-medtronic probe and everything went fine.However, when removing the probe/tracker a small white piece of plastic appeared on the liver.This was a laparoscopic case, so able to see it clearly and removed it and everything was fine.No x-ray was performed to see the broken off tip.It was after the ablation when removing the ultrasound tracking sensor, so no need for x-ray.They saw it clearly on camera and were able to remove it.No additional procedure was needed or performed.Doctor said he did not apply strong force, but port was narrow and he did acknowledge the small fit of it.Patient was very large.There was no patient injury.
Additional Manufacturer Narrative
Additional information: 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.
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 an ablation procedure, the sensor was attached to the non-medtronic probe and everything went fine.However, when removing the probe/tracker a small white piece of plastic appeared on the liver.This was a laparoscopic case, so able to see it clearly and removed it and everything was fine.No x-ray was performed to see the broken off tip.It was after the ablation when removing the ultrasound tracking sensor, so no need for x-ray.They saw it clearly on camera and were able to remove it.No additional procedure was needed or performed.Doctor said he did not apply strong force, but port was narrow (10 mm diameter port) and he did acknowledge the small fit of it.Patient was very large.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that one of the clips that secure the sensor to the catheter was broken and became separated from the catheter.The broken piece was not returned.It was reported that a component disengaged.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.A secondary review of the device history records found no potentially contributing factors.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 SX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20250144
• Report Number: 3004962788-2024-00106
• Device Sequence Number: 12590800
• Product Code: GEI
• UDI-Device Identifier: 10884521703346
• UDI-Public: 10884521703346
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/10/2025

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 Expiration Date: 02/13/2026
• Device Model Number: CABK8666L
• Device Catalogue Number: CABK8666L
• Device Lot Number: 28588146
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 09/10/2024; 01/07/2025; 04/08/2025
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 09/19/2024; 01/10/2025; 04/10/2025
• 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: Male