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

Model Number	SCD13
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: one device was returned for evaluation.The reported condition was confirmed.When the device was closed and the handle was released, the jaw did not open up.When the handle was pushed forward, the jaw opened.When the plastic nozzle/knob was broken open, plastic softening and deformation was observed on the plastic tabs.There was a transfer of plastic material onto the waveguide, indicating that the plastic softened.Engineering determined that the damage is probably due to the misalignment of the nozzle with inner tube and waveguide.Functional testing was performed with the returned dissector using a test lab generator and battery.The assembled device successfully produced the startup series of tones and the status light emitting diode(led) on the generator illuminated green, confirming proper assembly and device readiness for use.The assembled device was tested to confirm full functionality by activating the dual mode energy button with the clamping jaws open.The results were acceptable.The device was also activated with the jaws closed and submerged in glycerin bath at both power modes with acceptable results.The investigation identified the cause of the reported event to be misalignment of nozzle with inner tube and wave guide.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, cutter jaws couldn't be closed normally during the thyroidectomy.There was no patient injury.Communications from the investigations stated that the device did not lock on tissue nor tissue resection was necessary.

• 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: 9108283
• Report Number: 1717344-2019-01206
• Device Sequence Number: 3070325
• Product Code: LFL
• UDI-Device Identifier: 20884521195209
• UDI-Public: 20884521195209
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2019

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: 06/29/2022
• Device Model Number: SCD13
• Device Catalogue Number: SCD13
• Device Lot Number: 71810022X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1