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

Catalog Number	VC17
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	10/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device has been requested for return to livanova.Though the facility reported that the patient experienced reddened/burned skin, it was also reported that there were no serious effects to the patient as a result of the incident.No intervention has been reported by the customer at this time.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received a report that the handle of the vascuclear precision bipolar was noted to be warm during a vein harvesting procedure and the patient's skin appeared reddened/burned.The bipolar was replaced and the procedure was completed without further incident.The hospital biomedical engineer reportedly checked the cauterizing machine and was unable to identify any issues.Though the facility reported that the patient experienced reddened/burned skin, it was also reported that the patient is fine.No intervention to prevent permanent damage was reported.
Additional Manufacturer Narrative
The involved vascuclear precision bipolar was returned to livanova for evaluation.The tip of the bipolar device was identified to be damaged upon receipt.Visual inspection of the returned device identified biological material burned to the shaft of the bipolar.Electrical testing was conducted and the device functioned as expected.Further functional testing was not possible due to the broken tip of the device.As the issue could not be reproduced and full functional testing could not be performed, an exact root cause was not determined.However, previous reports of a similar nature indicate that this failure is possibly due to user technique.A supplier quality notification has been initiated in connection with this event.Additionally, it was suggested to the sales representative to instruct the customer to strictly adhere to the ifu to prevent recurrence of the event in case this was the result of user technique.

• Brand Name: VASCUCLEAR PRECISION BIPOLAR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 8092603
• Report Number: 1718850-2018-00021
• Device Sequence Number: 1446803
• Product Code: GEI
• UDI-Device Identifier: 00803622132384
• UDI-Public: (01)00803622132384(240)VC17(17)210930(10)1824800206
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 09/30/2021
• Device Catalogue Number: VC17
• Device Lot Number: 1824800206
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/25/2018
• Supplement Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1