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

Model Number	SCDA39
Medical Device Problem Codes	Failure to Cut (2587); Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during procedure, the dissector had stopped working.Device had stopped cutting ability just on the beginning of the case was detected.The dissector did not come into contact with any metal instruments.Another dissector was used with the same generator and battery and it worked fine.The dissector did not break.There was no patient injury.Medtronic's initial evaluation of the incident device found the dissector had a fractured waveguide.The broken piece was not returned.
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: d4 (udi), 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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found the dissector had a fractured waveguide.The broken piece was not returned, and the device showed signs of use.Functional testing found that the assembled device returned a green light and produced a welcome tone.The assembled device immediately alarmed when activated.The waveguide was inspected under magnification and the origin of the crack was identified.It was reported that there was a device cutting issue and no activation during the procedure.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The titanium waveguide became cracked from continued use after it may have come in contact with a metallic object.Use after damage can cause the cracked waveguide to break off.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: contact between the active blade and other metal objects (hemostats, clips, staples, retractors, etc.) may result in product damage, such as a broken blade.Pieces of a broken blade may fall into the surgical cavity causing unintended tissue damage.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: 23432648
• Report Number: 1717344-2025-01416
• Device Sequence Number: 8533632
• Product Code: LFL
• UDI-Device Identifier: 10884521592841
• UDI-Public: (01)10884521592841(17)300513(10)51340210X
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

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 Model Number: SCDA39
• Device Catalogue Number: SCDA39
• Device Lot Number: 51340210X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 10/31/2025; 11/13/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/03/2025; 12/03/2025
• 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: Unknown