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

Model Number	SCD48
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/06/2018
Type of Reportable Event	Serious Injury
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 laparoscopic band removal procedure, the surgeon noticed a burnt area on the patients stomach.The surgeon sutured the wound and has informed the patient of the issue.The surgeon was worried about the scab falling off and creating a hole in the stomach.It is uncertain as to whether it is a burn from our product or the hook diathermy.
Additional Manufacturer Narrative
Evaluation summary: one device sample 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 investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event of device-related burn.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 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.No excessive heating was observed during device activation.The investigation found the device to function normally and within specifications.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7629350
• Report Number: 1717344-2018-00844
• Device Sequence Number: 1861449
• Product Code: LFL
• UDI-Device Identifier: 20884521195223
• UDI-Public: 20884521195223
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2022
• Device Model Number: SCD48
• Device Catalogue Number: SCD48
• Device Lot Number: 70260203X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 06/22/2018; 08/08/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/20/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention