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

Model Number	VC17
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa received a report that plastic piece of the endoscopic vein harvesting system broke off and went in suction during a surgery.There is no report of any patient injury.
Additional Manufacturer Narrative
Patient information was not provided.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Livanova usa received a report that plastic piece of the endoscopic vein harvesting system broke off and went in suction during a surgery.There is no report of any patient injury.During follow up directly with the customer, livanova learned that the evh has not been used on the patient, since the item was received broken.Specifically, the wire was protruding out of jaw.Based on the above, the event has been reassessed as not reportable since the issue is always detectable before use and therefore it has improbable possibility to cause patient injury.The unit has been sent to livanova and will be investigated.
Event or Problem Description
See intial report.

• Brand Name: ENDOSCOPIC VEIN HARVESTING SYSTEM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIE
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16245284
• Report Number: 1718850-2023-00022
• Device Sequence Number: 12148304
• Product Code: GEI
• UDI-Device Identifier: 00803622132384
• UDI-Public: (01)00803622132384(240)VC17(17)251031(10)2228400125
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2023

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: 10/31/2025
• Device Model Number: VC17
• Device Lot Number: 2228400125
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2022
• Supplement Date Received by Manufacturer: 01/28/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown