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

Catalog Number	VC15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier was not provided.Patient sex was not provided.Patient ethnicity/race was not provided.(b)(6).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 relevant to the reported event is received, it will be provided in a supplemental report.Device not available for return.
Event or Problem Description
Livanova received a report that the plastic tip of the vascuclear precision bipolar broke off during the vein harvesting procedure and was deposited in the patient.The tip was removed by the surgeon and the device was swapped out to complete vein harvesting procedure.There was no report of patient injury.
Additional Manufacturer Narrative
One vc15 bipolar device was returned to livanova for evaluation.Visual inspection of the device was able to confirm the reported damage to the tip.However, the returned bipolar also was found to have a bent shaft and a puncture in the packaging, likely where the tip had been forced against a hard surface, indicating that any damage may have been exacerbated during product return.The damage identified appeared to be due to a sharp force at the tip, and was determined to be caused due to rough handling during shipment.Though the damage was confirmed, it is unknown what level of damage was exacerbated by rough handling during return shipment.As livanova is not aware of any other similar event and as the damage was determined to be caused by rough handling during shipment, no corrective action is deemed necessary at this time.

• 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: 8025103
• Report Number: 1718850-2018-00018
• Device Sequence Number: 1353111
• Product Code: GEI
• UDI-Device Identifier: 00803622132360
• UDI-Public: (01)00803622132360(240)VC15(17)210430(10)1811400124
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/26/2019

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: 04/30/2021
• Device Catalogue Number: VC15
• Device Lot Number: 1811400124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 02/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 78