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

Model Number	SCD13
Medical Device Problem Code	Intermittent Energy Output (4025)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was returned for evaluation.The returned product did not meet specification as received.Visual inspection of the disposable device revealed that the tip of the waveguide was broken off.The broken piece was not returned.The reported condition was confirmed.Investigation personnel performed functional testing on the returned hand piece using a test lab generator and battery.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.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.Ifu also states: do not use damaged components.Use of damaged components may result in injury to the patient or user.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the device did not activate.After 3 and a half hours the equipment stopped performing the dissection.The battery was changed, but continued to present the problem.To finalize the procedure, the tweezers were replaced with another one from the same lot and it worked without intercurrences.There was no patient injury.It has confirmed that the tip did not break and nothing fell into the patient cavity.

• 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: 8407840
• Report Number: 1717344-2019-00305
• Device Sequence Number: 312708
• Product Code: LFL
• UDI-Device Identifier: 20884521195209
• UDI-Public: 20884521195209
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153371
• 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): 03/11/2019

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: 04/27/2022
• Device Model Number: SCD13
• Device Catalogue Number: SCD13
• Device Lot Number: 71180174X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 70