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

Model Number	SCD396
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during procedure, the cutter tip broke and detached from the scabbard.The equipment section immediately investigated the incident.It was understood that during the operation of the patient, the intraoperative device alarmed and could not continue to work.The doctor took out the wireless ultrasonic hemostatic dissector and cleaned and wiped it.During the inspection, the grasping tooth of the cutter tip broke and fell off, so immediately stopped using it.Nothing fell on patient's cavity.It was replaced with similar device and it worked fine.There was no patient injury.

• 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: 12231606
• Report Number: 1717344-2021-01049
• Device Sequence Number: 17241461
• Product Code: LFL
• UDI-Device Identifier: 10884521807877
• UDI-Public: 10884521807877
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: 03/29/2025
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 00850184X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1