MAUDE Adverse Event Report: LIVANOVA USA VASCUCLEAR PRECISION BIPOLAR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	VC17
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier was not provided.Patient sex was not provided.Patient weight was not provided.Through follow-up communication with the customer, livanova usa learned that this is not the first occurrence of this issue.The customer reported that this issue has happened with at least one and potentially as many as four other patients in the past.Additional follow-up is being performed to gather information regarding the additional patients, which will be filed in separate complaints.The customer reported that in all cases, the same physician was conducting the procedure.As the vascuclear precision bipolar kit does not come with a trocar and does not have a light, clarification was requested regarding the event.The facility reiterated that the light inside of the trocar blistered the leg of the patient.It is unknown at this time exactly what part of the device the customer is referring to.Based on the previous reports of injury, the customer believes this may be a user issue and has scheduled retraining of the involved physician.If any additional information pertinent to the reported event is received, it will be submitted in a supplemental report.Device discarded by customer.
Event or Problem Description
On august 7, 2017, livanova usa received a user medwatch report (mw5071103) that the light inside the "trocar" of the vascuclear precision bipolar blistered the left leg of the patient in 3 areas during a procedure.The wound was dressed and the nurse checked on the patient 48 hours after the procedure to ensure no hematoma occurred.The customer reported that the patient is presently doing well.All other similar products were pulled from stock for investigation.
Additional Manufacturer Narrative
A livanova representative visited the facility to evaluate the event and determine root cause.After troubleshooting, it was determined that there was no device malfunction.The issue was the result of user technique which resulted in a friction burn.A complaint review was only able to identify one similar incident (1718850-2013-00303).However, in that case, it was not confirmed if the injury was a burn or irritation caused by friction.No other similar incidents were identified.The reported injury was minor and did not require medical intervention to preclude serious/permanent injury.The livanova representative provided training to all involved personnel, including an explanation of how friction burns can be caused by the device and recommendations on how the harvesting techniques can be varied to avoid this situation in the future.Based on the information above, this event has been reevaluated as non-reportable, and the medwatch report is being retracted.

• Brand Name: VASCUCLEAR PRECISION BIPOLAR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): LIVANOVA USA; 14401 w. 65th way; arvada CO 80004
• MDR Report Key: 6833908
• Report Number: 1718850-2017-00015
• Device Sequence Number: 11162970
• Product Code: GEI
• UDI-Device Identifier: 00803622132384
• UDI-Public: 00803622132384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K102983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: VC17
• Device Lot Number: 1707900211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 09/27/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 10/20/2017
• 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: Other
• Patient Age: 42 YR