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

Model Number	SCD13
Medical Device Problem Codes	Overheating of Device (1437); Self-Activation or Keying (1557)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a thyroid lobectomy, the device¿s jaws and shaft was hotter than in previous uses.After activation and applying the jaws for a subsequent bite, the jaws would begin to create tissue effect without even depressing the blue energy button.The patient also had some minor blanching of the skin created by the shaft coming in contact with the skin.Medical intervention was not required.
Additional Manufacturer Narrative
Additional info: correction: evaluation summary: one device sample was received for evaluation.Without the original packaging or a reported lot number, the investigator cannot determine if the product was within the assigned expiration date at the time of reported incident.The returned product met specification as received.Visual inspection found no defects.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 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 found the device to function normally and within specifications.The reported lot number 72140229x is not a valid lot number for this product, therefore no examination of the manufacturing records could be performed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a thyroid lobectomy, the device¿s jaws and shaft was hotter than in previous uses.After activation and applying the jaws for a subsequent bite, the jaws would begin to create tissue effect without even depressing the blue energy button.The patient also had some minor blanching of the skin created by the shaft coming in contact with the skin.Superficial burn treated with triple antibiotic ointment.
Additional Manufacturer Narrative
Additional:correction: evaluation summary: one device was received for evaluation.This device had 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 product met specification as received.Visual inspection found no defects.The customer reported overheating of device, and self-activation.The reported condition was not confirmed.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 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.This unit does not meet the requirements for a manufacturing or (service) failure.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: 7080736
• Report Number: 1717344-2017-06327
• Device Sequence Number: 19282373
• Product Code: LFL
• UDI-Device Identifier: 20884521195209
• UDI-Public: 20884521195209
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K141371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2018

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: 08/01/2022
• Device Model Number: SCD13
• Device Catalogue Number: SCD13
• Device Lot Number: 72140229X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 12/20/2017; 01/25/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 01/16/2018; 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1