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

Model Number	SCD7A39
Medical Device Problem Codes	Failure to Fire (2610); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	01/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: scd7a39, sonicision 7 dissector scd7a39 39 cm (lot # 53090273x); scd7a39, sonicision 7 dissector scd7a39 39 cm (lot # 53090277x).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 a laparoscopic uterine myomectomy, the first device used at the beginning of the case malfunctioned, displaying a flashing red light and emitting an audible error tone.The surgeon then requested that a second device be opened.After only a few minutes of use, while cutting through the myometrium, the active blade of the second device snapped off and fell into the patient.X-ray and fluoroscopy were used to locate the detached blade, which was ultimately found near the liver and small bowel.This incident was estimated to have added approximately three hours to the procedure.The device had functioned normally prior to the blade disengagement.Following retrieval of the blade, a third device was opened; however, it also produced a red error tone and stopped working.A fourth device was then opened and was used to complete the procedure.
Additional Manufacturer Narrative
D10 concomitant product: scd7a39, sonicision 7 dissector scd7a39 39 cm (lot#unknown) 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 found the dissector had a damaged waveguide.The device showed evidence of use.Functional testing noted 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 the device had no activation during the procedure.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue could occur if the titanium waveguide became cracked from continued use after it came into contact with a metallic object.Continued use after damage could 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.A secondary review of the device history records found no potentially contributing factors.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: 24234492
• Report Number: 1717344-2026-00145
• Device Sequence Number: 8980757
• Product Code: LFL
• UDI-Device Identifier: 10884521794795
• UDI-Public: (01)10884521794795(17)301104(10)53090273X
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCD7A39
• Device Catalogue Number: SCD7A39
• Device Lot Number: 53090273X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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: PLEASE SEE NOTE ON H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Unknown
• Patient Weight: 104 KG