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

Catalog Number	VC17
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	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information has been provided.The complained device has been requested but not yet received.A review of the dhr did not identify any deviations or non-conformities 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 has been informed that, at the end of a procedure, while trying to remove endoscopic vein harvesting system endoscopic vein harvesting system vc17 from the patients leg incision, the tip broke off in the patient.The piece was removed and nothing left in patient.The procedure was completed as planned.There is not report of any patient injury.
Additional Manufacturer Narrative
The returned device vascuclear was inspected and the tips found to be damaged and non-functional.The plastic tip that cover the blade of the device was broken off.The investigation confirmed the reported condition.The subassembly of the claimed item is manufactured by a livanova¿s supplier.This failure is determined to likely have been originated from the supplier's manufacturing process.The supplier has been made aware of the reported event.Frequency of this type of event is low (remote).No other corrective action will be undertaken.A review of the dhr did not identify any deviation or non-conformity relevant with the case.Livanova will keep monitoring the market.

• Brand Name: VASCULAR 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: 8674497
• Report Number: 1718850-2019-00010
• Device Sequence Number: 11355944
• Product Code: GEI
• UDI-Device Identifier: 00803622132384
• UDI-Public: (01)00803622132384(240)VC17(17)220131(10)1902200214
• 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): 09/10/2019

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: 01/31/2022
• Device Catalogue Number: VC17
• Device Lot Number: 1902200214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1