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

Model Number	SCDA39
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the beginning of the operation, when the ultrasonic dissector was used to coagulate the small blood vessels at the adhesion between the lung and the chest wall, the blade¿s insulation layer had detached and was charred.There was no patient injury and nothing fell on the patient¿s cavity.
Additional Manufacturer Narrative
D10 concomitant products: scda39, ultrason dissect scda39 curved jaw 39cm (lot#:41910190x) 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: g3.Correction: b5.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 at the beginning of the operation, when the two ultrasonic dissector was used to coagulate the small blood vessels at the adhesion between the lung and the chest wall, the blade's insulation layer had detached and was charred.There was no patient injury and nothing fell on the patient's cavity.
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 noted that the jaw liner was degraded and lifted off of the jaw at the tip of the device.Functional testing found that the jaw liner damage is caused by the device jaws being clamped and activated multiple times with too little or no tissue present in the jaws.Extended activation under this condition will cause the jaw liner to melt and become damaged.It was reported that the blade¿s insulation layer had detached and was charred.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.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: the user's guide advises users not to activate the instrument with the clamping jaw closed unless there is tissue present, as doing so may damage the device jaws.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: g3, h3 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the jaw liner was degraded and lifted off of the jaw at the tip of the device.It was reported that the jaw liner was degraded and had detached.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.Jaw liner damage is caused by the device jaws being clamped and activated multiple times with too little or no tissue present in the jaws.Extended activation under this condition will cause the jaw liner to melt and become damaged.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.The instructions included with this device provide the following guidance: do not activate the instrument with the clamping jaw closed unless there is tissue present, as doing so may damage the device jaws.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: b3, b5, g3, 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 at the beginning of the operation, the output power of the two dissectors fluctuates.Sometimes high and sometimes low and when used to coagulate the small blood vessels at the adhesion between the lung and the chest wall, the blade¿s insulation layer had deformed, detached and was charred after only about 3 minutes of initial use.After the disposable blade was burned out, it was replaced with a new one and it worked normally.There was no patient injury and nothing fell on the patient¿s cavity.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 rfr - sedcmcdtc (component disengaged) 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 at the beginning of the operation the output power of the two dissectors fluctuates, sometimes high and sometimes low, and when used to coagulate the small blood vessels at the adhesion between the lung and the chest wall.The blade¿s insulation layer had deformed, detached and was charred after only about 3 minutes of initial use.Both dissectors were broken off.After the disposable blade was burned out, it was replaced with a new one and it worked normally.There was no patient injury and nothing fell on the patient¿s cavity.
Additional Manufacturer Narrative
Correction: h6 removed: rfr additional information: 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.

• 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: 23544121
• Report Number: 1717344-2025-01499
• Device Sequence Number: 9775536
• Product Code: LFL
• UDI-Device Identifier: 10884521592841
• UDI-Public: (01)10884521592841(17)290708(10)41910190X
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 05/28/2026

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: 41910190X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 02/16/2026; 02/17/2026; 03/23/2026; 04/28/2026; 05/25/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 11/25/2025; 02/16/2026; 02/18/2026; 03/24/2026; 05/13/2026; 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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 Sex: Unknown