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

Model Number	SCD7A26
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.10.Concomitant product: scd7a26, sonicision 7 dissector scd7a26 26 cm (lot# 50150179x); scd7a26, sonicision 7 dissector scd7a26 26 cm (lot# 50150179x).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
According to the reporter, during use, the jaws of the three dissectors melted/disfigured.No piece from the jaw liner melted off into the patient's cavity.There was no patient injury.Medtronic's initial evaluation of the incident device found that the jaw liner degraded, and pieces of the jaw liner were missing.
Additional Manufacturer Narrative
Additional information: 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 degraded.Pieces of the jaw liner were missing.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.Manufacturing does 100% inspection during the assembly and packaging processes.The defective sample would have been rejected if found prior to shipping, had it been an assembly defect.It was reported that the jaws of the three dissectors melted/disfigured.The reported issue was 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: 23757885
• Report Number: 1717344-2025-01587
• Device Sequence Number: 15978841
• Product Code: LFL
• UDI-Device Identifier: 10884521794788
• UDI-Public: (01)10884521794788(17)300114(10)50150179X(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2026

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: SCD7A26
• Device Catalogue Number: SCD7A26
• Device Lot Number: 50150179X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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