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

Catalog Number VC15

Device Problem Difficult to Open or Close (2921)

Patient Problem Blood Loss (2597)

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Date of event is unknown.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.The present mfr report number was submitted on january 30, 2020 as mfr report number 1718850-2020-00002 initial report.The first and second acks were successfully processed (coreid: (b)(4)).The third ack failed as it contained the error message that there was duplicate report.Investigation confirmed that the report number 1718850-2020-00002 was indeed a duplicate due to an error while creating an importer report number.To avoid reoccurrence, the relevant personal has been retrained on the procedure for importer report submission and the present report has been submitted with a different mfr report number (1718850-2020-00017 initial report).

Event Description

Livanova usa in has received a report that, during an endoscopic vessel harvesting procedure, the grab of the bipolar broke off.A side vessel was damaged and started bleeding.There is no report of any patient injury.

• Brand Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIE
• Type of Device: ENDOSCOPIC VEIN HARVESTING SYSTEM
• Manufacturer (Section D): LIVANOVA USA, INC; 14401 w.65th way; arvada, co
• Manufacturer (Section G): LIVANOVA USA, INC; 14401 w.65th way; arvada, co
• Manufacturer Contact: enrico greco ; 14401 w.65th way; arvada, co
• MDR Report Key: 9989290
• MDR Text Key: 188666714
• Report Number: 1718850-2020-00017
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/17/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: VC15
• Device Lot Number: 1922600113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1