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

Model Number	SCD7A26
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to the reporter, during procedure, the device stopped working due to something around the jaw.There were pieces found lodged inside the jaw that were dark and almost plastic like.The case was very bloody.Advised the nurse to clean the jaws in water but the nurse kept using raytec to wipe the jaw and the raytec got caught on the outside of the jaws.Once dislodging the pieces from the jaw, the error red light came on and it smoked when activated.Replaced the device and used the same generator and same battery and the next device worked fine.
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.
Event or Problem Description
According to the reporter, during whipple procedure, the device stopped working due to particles inside the joint of the jaw.It worked for about 4 hours before it stopped.It was unknown if the plastic part in the jaws melted.It was also unknown if any part of the device completely detached or if any piece fell into the patient¿s cavity.X-ray was not needed to locate the piece in order to retrieve it, and there was no any additional medical procedure needed to remove the piece from the patient.There were pieces found lodged inside the jaw that were dark and almost plastic like.The case was very bloody.Advised the nurse to clean the jaws in water but the nurse kept using raytec to wipe the jaw and the raytec got caught on the outside of the jaws.Once dislodging the pieces from the jaw, the error red light came on and it smoked when activated.Replaced the device and used the same generator and same battery and the next device worked fine.There was no patient injury.

• Brand Name: SONICISION
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19046461
• Report Number: 1717344-2024-00892
• Device Sequence Number: 8548937
• Product Code: LFL
• UDI-Device Identifier: 10884521794788
• UDI-Public: 10884521794788
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/28/2024

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: 30460162X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/29/2024
• Date Device Manufactured: 02/20/2023
• 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