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

Model Number	SCD48
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/30/2020
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 the waveguide to be broken.Functional testing found that the assembled device returned a green light and a welcome tone using a test lab generator and battery, but immediately returned a red led indicator with an error tone (alarm activation) when the device was activated.It was reported that the device did not activate when keyed.The reported issue could not be confirmed.The most likely cause could not be established from the information available.Broken waveguide can happen if it comes contact with metal objects during use causing the active blade to crack and may eventually break off.This issue is specific to ultrasonic dissectors.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: 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, prior to use, the dissector did not activate.A similar device was used to proceed with the case.There was no patient involvement.Medtronic initial investigations found out that the tip of the waveguide was broken off and was not 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: 10525575
• Report Number: 1717344-2020-01028
• Device Sequence Number: 19638925
• Product Code: LFL
• UDI-Device Identifier: 10884521195226
• UDI-Public: 10884521195226
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K141371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2020

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: 11/02/2024
• Device Model Number: SCD48
• Device Catalogue Number: SCD48
• Device Lot Number: 93030261X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1