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

Model Number	SCD391
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection found the device had been soiled, indicating that it had been used.The tip of the waveguide had fractured and disengaged.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 received a red light and would not activate prior to use.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the waveguide was broken.The product analysis noted evidence that the device was not used as intended.The titanium waveguide became cracked from continued use after it may have come in contact with a metallic object.The crack propagated until the waveguide fractured.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 unintended damage to tissue or device failure.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, when the device was opened and attached to generator and battery pack, it was a green lamp, but as soon as it was activated, it turned into a red lamp and the product could not be used.It was able to be used without problems after replacement.There was no patient involved.Medtronic's initial evaluation of the incident device tip of the waveguide had fractured and disengaged.The broken piece was returned.

• Brand Name: SONICISION
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 12140008
• Report Number: 1717344-2021-00951
• Device Sequence Number: 13860978
• Product Code: LFL
• UDI-Device Identifier: 10884521052659
• UDI-Public: 10884521052659
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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 Expiration Date: 01/06/2026
• Device Model Number: SCD391
• Device Catalogue Number: SCD391
• Device Lot Number: 03570290X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2021
• Initial Report FDA Received Date: 07/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1