MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH HARVESTER; LAPAROSCOPE, GENERAL

Model Number	MCVS550HVJ
Medical Device Problem Code	Failure to Conduct (1114)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during vein harvesting procedure, there was failure in the electrical continuity.The harvester was not used and surgery was converted to open vein harvest.Product was not changed out, procedure was completed successfully.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on may 24, 2018.Upon further investigation of the reported event, the following information is new and/or changed: (additional device information - added exp date), (date received by manufacturer), (indication that this is a follow-up report), (follow-up due to additional information and device evaluation), (device evaluated by manufacturer), (device manufacture date), (b)(4).The returned sample was visually inspected and it was noted that the distal end of the v-cutter tip was cracked.The body liquid or blood residues were found around the v-cutter tip and the sides of the ground electrode.No visual damage was found inside the bipolar connector.The electrical circuit was also tested by testing the electrical resistance.All results were measured within product standard.There was no anomalies found with the returned unit and it was verified to function as intended.The complaint was not confirmed and a definitive root cause was not able to be determined.The cracked v-cuter tip most likely resulted from the force applied to the distal end of the v-cuter during insertion of the device into the tunnel.It is likely that the v-cutter tip was twisted with force, creating a small gap between the v-cutter tip and up/low parts therefore allowing the body fluid or blood to seep in.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH HARVESTER
• Common Device Name: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7542796
• Report Number: 1124841-2018-00101
• Device Sequence Number: 2413357
• Product Code: GCJ
• UDI-Device Identifier: 00699753021075
• UDI-Public: (01)00699753021075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2018

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: 04/30/2020
• Device Model Number: MCVS550HVJ
• Device Catalogue Number: N/A
• Device Lot Number: 75K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention