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

Model Number	SCDA39
Medical Device Problem Codes	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	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant products: scba, battery scba (serial#: unknown), scgaa, reusable generator a scgaa (serial#: unknown) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the springs had disengaged from the device.Damages were observed at the generator horn interface.The dissector has a damaged waveguide.The waveguide tip was fractured and not returned.Functional testing found that the damages observed were due to misuse, most likely a forceful assembly.A device with a damaged mandrel assembly wouldn't pass the end of line tests.The waveguide was inspected under magnification and the origin of the crack was identified.It was reported that the device did not activate during procedure.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur 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.
Event or Problem Description
It was reported that during procedure, after about 10 minutes the device presented a red light.The surgeon cleaned and re-assembled but without success.Another dissector was used with the same generator and battery and it worked normally during the rest of the case.No detached piece fell into the patient's cavity.There was no patient harm/injury.Medtronic's initial evaluation of the incident device found that the dissector has a damaged waveguide.The waveguide tip was fractured and not returned.

• 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: 24586934
• Report Number: 1717344-2026-00358
• Device Sequence Number: 13107882
• Product Code: LFL
• UDI-Device Identifier: 10884521592841
• UDI-Public: (01)10884521592841(17)300309(10)50640215X
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 03/12/2026

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: 50640215X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 42 YR
• Patient Sex: Female