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

Model Number	SCD391
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the disposable device revealed that the tip of the waveguide had fractured and disengaged.The broken piece was returned.The device showed evidence of use.It was reported that the device broke 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 found to be broken.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.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 and/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, the device broke.There was no patient involvement.Medtronic's initial evaluation of the incident device found that the tip of the waveguide had fractured, disengaged but 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
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13677908
• Report Number: 1717344-2022-00259
• Device Sequence Number: 17366723
• Product Code: LFL
• UDI-Device Identifier: 10884521052659
• UDI-Public: 10884521052659
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2022

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: 12/06/2025
• Device Model Number: SCD391
• Device Catalogue Number: SCD391
• Device Lot Number: 03250039X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• 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