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

Model Number VC17

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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.

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.

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 Description

See intial report.

• Brand Name: ENDOSCOPIC VEIN HARVESTING SYSTEM
• Type of Device: 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
• MDR Text Key: 308918677
• Report Number: 1718850-2023-00022
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00803622132384
• UDI-Public: (01)00803622132384(240)VC17(17)251031(10)2228400125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VC17
• Device Lot Number: 2228400125
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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