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

Model Number	SCD396
Medical Device Problem Codes	Break (1069); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2020
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 tip of the waveguide had fractured and disengaged and the broken piece was returned.The battery contact pins were bent.The assembled device returned a green light and produced a welcome tone, and immediately alarmed when activated.The waveguide was inspected under magnification and the origin of the crack was identified.It was reported that the device broke during use and the waveguide broke when cleaning.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if 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 evaluation detected an unreported condition: the unit had a connector pin failure.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, during a hysterectomy procedure, the device¿s clamp broke during cleaning and while in use.Nothing broke off.They replaced the device to complete the case.There was no patient injury.No further information available.Medtronic investigation found that the 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: 11377990
• Report Number: 1717344-2021-00301
• Device Sequence Number: 3712221
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 10/15/2024
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 92820170X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1