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

Model Number	SCD13
Medical Device Problem Code	Device Stops Intermittently (1599)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident ultrasonic dissector was returned for evaluation.Visual inspection of the disposable hand piece revealed that the device had been used and the static part of the jaw had broken off.The broken piece was returned with the rest of device.The remaining waveguide and the broken piece were inspected under magnification to identify the point of initial contact and fracture.It was concluded that the titanium waveguide fractured during use and eventually broke off.The titanium waveguide may have came in contact with a hard metallic object such as hemostat or retractor as evidenced by the break point and metallic scraping.The user¿s guide for this system warns: 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.
Event or Problem Description
The customer originally reported that the device stopped working during the procedure.Another dissector was opened and used to complete the case.There was no patient injury.The device was returned for evaluation and a piece of the active waveguide was disengaged from the device.The broken piece was returned with the remainder of the dissector.

• 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: 6700795
• Report Number: 1717344-2017-05562
• Device Sequence Number: 16496866
• Product Code: LFL
• UDI-Device Identifier: 10884521195202
• UDI-Public: 10884521195202
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K141371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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: 02/01/2021
• Device Model Number: SCD13
• Device Catalogue Number: SCD13
• Device Lot Number: 60320107X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1