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

Model Number	CA30L2N
Medical Device Problem Codes	Defective Device (2588); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: cabk8666l, sensor (b)(6) lap ultrasound tracking (lot#25974287).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 navigation component did not work and all diagnostics were clear on machine.The second image on the navigation screen to the right was rapidly blinking and unable to use the navigation on the procedure.Navigation did not work on the machine.The procedure was not able to be completed, and the procedure was aborted.
Additional Manufacturer Narrative
Additional information: b5, d2 (common device name), d3 (mfr name, street 1, mfr city, country code, postal code), g3, h6 (coding: fdp, ime, imf) new information has been received, and reassessment of the complaint found that it is no longer a reportable event.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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 navigation component did not work and all diagnostics were clear on machine.The second image on the navigation screen to the right was rapidly blinking and unable to use the navigation on the procedure.Navigation did not work on the machine.The navigation portion of the procedure had to be aborted and restarted with utilizing just the ablateoption on the sx machine.There was no patient injury.

• Brand Name: EMPRINT SX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer (Section G): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai CO 20111 4; CH 201114
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19143743
• Report Number: 1717344-2024-00991
• Device Sequence Number: 12728204
• Product Code: GEI
• UDI-Device Identifier: 10884521703292
• UDI-Public: 10884521703292
• 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
• Report Date (Section B): 05/02/2024

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 Expiration Date: 12/22/2024
• Device Model Number: CA30L2N
• Device Catalogue Number: CA30L2N
• Device Lot Number: 26481121
• 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: Not provided
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 04/19/2024
• Supplement Report FDA Received Date: 05/02/2024
• Date Device Manufactured: 12/23/2023
• 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: PLEASE SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown