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

Catalog Number	VC17
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device has been received at livanova usa inc for investigation.Investigation is ongoing.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc has received a report that, during a procedure using a endoscopic vein harvesting system, the spoon broke off in the patient's leg.The part was retrieved.There is no report of any patient injury.
Additional Manufacturer Narrative
The components of the kit were inspected.The components were all found to appear defect free and without damage, with exception of the spoon retractor.The spoon retractor rail was found to be dethatched from the spoon retractor shaft.The spoon and rail were reassembled and inspected to identify the damage that caused the separation between the components.It was observed that the proximal end of the rail fit appropriately into the handle of the retractor spoon.On the distal, spoon end, it was observed that the two tabs extending from the rail that engage into the proximal end of the spoon were missing, and the areas where the tabs were supposed to be were malformed.The retractor spoon was found to be damage and defect free.A review of the dhr did not identify any deviation or non-conformity relevant with the case.The investigation confirmed the reported event.The failure is ascribable to a molding defect during the manufacture of the retractor rail.This component is supplied by an outside manufacturer.To prevent reoccurrence, a supplier quality notification has been issued.As this is the unique event in the last 12 months and the risk associated to this type of event is acceptable, no other corrective action will be undertaken livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: ENDOSCOPIC VEIN HARVESTING SYSTEM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 9201888
• Report Number: 1718850-2019-00021
• Device Sequence Number: 16920845
• Product Code: GEI
• UDI-Device Identifier: 10803622132381
• UDI-Public: (01)10803622132381(240)VC17(17)220630(10)1916900207
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/17/2019

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: 06/30/2022
• Device Catalogue Number: VC17
• Device Lot Number: 1916900207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 12/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1