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

Model Number	SCDA13
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2020
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 a open liver resection procedure, the device's insulation on non active jaw came off while being cleaned.Nothing fell into the patient cavity.They replaced the device to complete the case.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection of the disposable hand piece found that the jaw liner had melted and detached 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.

• 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: 9912503
• Report Number: 1717344-2020-00381
• Device Sequence Number: 16961948
• Product Code: LFL
• UDI-Device Identifier: 10884521592827
• UDI-Public: 10884521592827
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K180149
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: 11/12/2024
• Device Model Number: SCDA13
• Device Catalogue Number: SCDA13
• Device Lot Number: 93110171X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1