MAUDE Adverse Event Report: COVIDIEN SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Model Number	SCDA39
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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.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 procedure, the dissector was used for the first time, and when assembled, the spring came off because it did not fit properly.A different dissector was used with the same generator and battery, and it functioned normally.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6 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 procedure, the dissector was used for the first time, and when assembled, the spring came off because it did not fit properly.The spring did not fell inside the patient's cavity.A different dissector was used with the same generator and battery, and it functioned normally.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3 h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found that the springs had disengaged from the device.Damages were observed at the generator horn interface.The device was partially separated above the pin connectors.The device showed evidence of use.Functional testing was performed with the returned dissector using a test lab generator and battery.The assembled device successfully produced the startup series of tones and the status led on the generator illuminated green, confirming proper assembly and device readiness for use.The jaws of the device were unable to close due to the damage to the device.The device manufacturing end line tests were reviewed and found the device passed testing.It was reported that the component disengaged and the device was difficult to assemble.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.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: SONICISION
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN; 6044 longbow court; boulder CO 80301 3299
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 23956528
• Report Number: 1717344-2026-00004
• Device Sequence Number: 5739110
• Product Code: LFL
• UDI-Device Identifier: 10884521592841
• UDI-Public: (01)10884521592841(17)300508(10)51290072X
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K180149
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

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: SCDA39
• Device Catalogue Number: SCDA39
• Device Lot Number: 51290072X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/21/2026; 02/27/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/05/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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: Unknown