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

Model Number	SCD48
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2018
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, intra-operatively, the two device¿s blade snapped off four times during activation.It was suspected to be in contact with metal.The broken pieces that fell into patients cavity are all retrieved.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: two devices were returned for evaluation.These devices have been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned products did not meet specification as received.Visual inspection of each of the two disposable devices revealed that the tip of the waveguide was broken off.The broken pieces were returned.Investigation personnel performed functional testing on the returned hand piece using a test lab generator and battery.For each device, the assembled device returned a green light and a welcome tone, but immediately returned a red light-emitting diode (led) indicator with an error tone (alarm activation) when the device was activated.This characteristic indicated that the device was not functional.The waveguide had its tip missing, and the missing piece was returned.Investigation personnel concluded that the titanium waveguide was in use when it cracked and broke off, and may have come in contact with any of the following; hemostats, clips, staples, retractors, etc.During use.The investigation identified the cause of the reported event to be user error.The device instructions for use currently contain a warning against contact between the dissector tip and metal objects (hemostats, clips, staples, retractors, etc.) during activation.Contact with metal objects during use will cause the active blade to crack and may eventually break off.This issue is specific to ultrasonic dissectors.The instructions for use (ifu) advises device users to visually inspect all system components for breaks, cracks, nicks, or other damages prior to use.Instructions for use (ifu) also states: do not use damaged components.Use of damaged components may result in injury to the patient or user.No update to the risk management file is required at this time.1717344-2018-00470-1 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: 7421018
• Report Number: 1717344-2018-00470
• Device Sequence Number: 554886
• Product Code: LFL
• UDI-Device Identifier: 20884521195223
• UDI-Public: 20884521195223
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 07/13/2022
• Device Model Number: SCD48
• Device Catalogue Number: SCD48
• Device Lot Number: 71950286X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1