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

Model Number	SCD7A39
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	08/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the surgery started with the clamp and it worked well, after a while, the generator showed a red light, it was disassembled and reassembled and the error persists, the generator and battery were changed and it continued to show red; the clamp was changed and everything worked.No part of the dissector broke.There was no patient injury.Medtronic's initial evaluation found that the device showed evidence of use.Debris was noted under the activation button.
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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found the device showed evidence of use.Debris was noted under the activation button.Functional testing noted that the assembled device alarmed prior to activation attempts being made.The torque adaptor had melted.The remnants of the torque adaptor were scattered in the handle body.A larger piece likely became wedged under the activation button and interfered with its proper function.Further examination of the torque adaptor and interfacing components, the damage appeared to be from heat, likely friction.It was reported that there was no activation during the procedure.The reported issue was confirmed.The most likely cause could not be established from the information available.This issue can occur due to inadequate torquing during assembly, component¿s geometry or positioning on waveguide is out of specification, or assembly positioning and tolerances bias torque adaptor against proximal wall of inner torque nozzle during use increasing friction.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: 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: 24777893
• Report Number: 1717344-2026-00503
• Device Sequence Number: 6132783
• Product Code: LFL
• UDI-Device Identifier: 10884521794795
• UDI-Public: (01)10884521794795(17)291008(10)42830235X(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K212301
• 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
• Report Date (Section B): 06/03/2026

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: SCD7A39
• Device Catalogue Number: SCD7A39
• Device Lot Number: 42830235X
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 06/03/2026
• 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 Age: 65 YR
• Patient Sex: Female