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

Model Number	SCD396
Medical Device Problem Codes	Break (1069); Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2019
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 noted that the tip of the waveguide was broken off and fractured.The broken piece was not returned.Functional testing on the returned hand piece returned a green light and a welcome tone, but immediately returned a red light-emitting diode (led) indicator with an error tone (alarm activation) when the device was activated.This characteristic indicated that the device was not functional.It was reported that the device received a red light and would not activate during use.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when the titanium waveguide was in use and may have come in contact with any of the following; hemostats, clips, staples, retractors, etc.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: visually inspect all system components for breaks, cracks, nicks, or other damages prior to use.Do not use damaged components.Use of damaged components may result in injury to the patient or user.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure for endometriosis, the dissector stopped working.Another device was used to complete the procedure.There was no patient injury.Medtronic's initial evaluation of the incident found that the device's waveguide tip was broken off and fractured.The broken piece was not returned.Upon follow up, the dissector broke and no parts fell into patient cavity.

• 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: 10405564
• Report Number: 1717344-2020-00876
• Device Sequence Number: 14226571
• Product Code: LFL
• UDI-Device Identifier: 10884521807877
• UDI-Public: 10884521807877
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

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: 03/10/2024
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 90590056X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2020
• Initial Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR