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

Model Number	SCDA13
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.The picture showed that the jaw liner had melted and deformed during use.The reported condition was confirmed.The investigation identified a damaged jaw liner.Jaw liner damage is caused by the device jaws being clamped and activated multiple times with too little or no tissue present in the jaws.Extended activation under this condition will cause the jaw liner to melt.The investigation identified the cause of the reported event to be user error.The instructions for use(ifu) warns: do not activate the instrument with the clamping jaw closed unless issue is present.This could damage the device jaws and cause injury to the patient.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during pre-operative demonstration, the clinician tried the new device, activating first with the jaws open and closing them.The heat melted the teflon and the device did not give any alarm.The photo submitted showing that the jaw liner was melted.There was no patient involvement.

• 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: 10046245
• Report Number: 1717344-2020-00502
• Device Sequence Number: 19545134
• Product Code: LFL
• UDI-Device Identifier: 20884521592824
• UDI-Public: 20884521592824
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K180149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2020

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: 12/17/2023
• Device Model Number: SCDA13
• Device Catalogue Number: SCDA13
• Device Lot Number: 83410022X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1