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

Catalog Number	VC17
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.The initial reported stated that the event happened in (b)(6) 2017 and the hospital's risk management department held onto the item and just released the device.The involved device has been returned to livanova usa for evaluation.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 tip of the vascuclear precision bipolar broke into multiple pieces during a procedure.There was no report of patient injury.
Additional Manufacturer Narrative
As the broken jaw fragments were not returned for investigation, a root cause could not be clearly identified.In previous cases, this type of issue has been seen due to excessive torsion of the device while the jaws were in the open position.The instructions for use for this device states "do not advance or torque the instrument with the jaws open or use the jaws for spread dissection.These actions will damage the instrument.¿ it is unknown if this was the cause of the issue in this case.The build for this lot number was for a total of 45 kits.There have been no other reports of broken jaws within this lot number.
Additional Manufacturer Narrative
The involved product was returned to livanova usa for investigation.Visual inspection of the returned device identified that both the plastic guards or jaws were missing from the tip of the bipolar.The missing jaws were not found anywhere inside the packaging or on the device.A supplier quality notification was issued to the supplier of the device to investigate the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• 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: 7232127
• Report Number: 1718850-2018-00002
• Device Sequence Number: 13951687
• Product Code: GEI
• UDI-Device Identifier: 00803622132384
• UDI-Public: (01)00803622132384(240)VC17(17)200430(10)1710100055
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2018

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: 04/30/2020
• Device Catalogue Number: VC17
• Device Lot Number: 1710100055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: 01/11/2018
• Supplement Date Received by Manufacturer: 02/09/2018; 03/07/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 03/07/2018; 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1