MAUDE Adverse Event Report: LIVANOVA USA INC ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIE; ENDOSCOPIC VEIN HARVESTING SYSTEM

Catalog Number	VC15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The involved device has been requested for return to livanova for investigation and it has not yet been returned.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 usa in has received a report that, during an endoscopic vessel harvesting procedure, one of the two jaw broke inside the patient¿s leg.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
One evh bipolar from vc15 lot 1922600113 was returned for the complaint of a clamp or jaw component breaking while in use on a patient.The returned bipolar device was found to have one of plastic jaw pieces missing.There was significant blood contamination noted on the blade, and minor blood contamination noted on the rest of the tip.The missing jaw piece was not located among the returned goods.The "cut" slider was found to function and appropriately actuate the blade.The "clamp" slider was found not to move and did not actuate the jaws of the device.The device was soaked in wescodyne solution to loosen up potential blood contamination solidified in the working mechanism.The clamp slider was then able to be actuated.The jaw was visually inspected.There was significant blood contamination inside the bottom, remaining jaw.The top jaw was cleanly broken off, and no jagged edges were observed.This break pattern indicates that the top jaw likely broke off while the device was being advanced with the jaw in the open position.A review of the dhr did not identify any deviations, non-conformities or material scrap/requests relevant to the reported issue.One other complaint was received for same lot of claimed kit with a different issue on the bipolar instrument.The investigation confirmed the reported condition.The top component of the jaw was observed to have been broken off of the tip of the bipolar likely occurs when device is.This type of damage is consistent with incorrect use of the instruments during the procedure.Specifically, the device is not intended to be advanced while in tissue with the jaws in the "open" configuration.On the product labeling, a caution statement is included recommending to "do not advance or torque the instrument with the jaws open or use the jaws for spread dissection.These actions will damage the instrument." livanova will keep monitoring the market.

• Brand Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIE
• Common Device Name: ENDOSCOPIC VEIN HARVESTING SYSTEM
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 10023456
• Report Number: 1718850-2020-00021
• Device Sequence Number: 2714815
• Product Code: GEI
• UDI-Device Identifier: 00803622132360
• UDI-Public: (01)00803622132360(240)VC15(17)220831(10)1922600113
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/09/2020

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: 08/31/2021
• Device Catalogue Number: VC15
• Device Lot Number: 1922600113
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1