MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION VIRTUOSAPH PLUS, WITH RADIAL; LAPAROSCOPE, GENERAL

Model Number VSP550EX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Injury (2348)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, 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.For this reason, terumo references evaluation conclusion code.Injury.Device operates differently than expected.Results pending completion of evaluation.Conclusion not yet available-evaluation in progress.

Event Description

The user facility reported to terumo cardiovascular that during vein harvesting procedure, the cutter slid out easily and damaged the patient's vein.The issue was resolved by opening the leg and taking the vein.Product was not changed out.Procedure was completed successfully.

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 march 20, 2018.(b)(4).The sample was not returned for evaluation; therefore, thorough investigation could not be performed and definitive root cause can not be determined.Device history records for the affected product code/lot number combination were reviewed and indicated no anomaly related to the event.The possible root causes would be due to unintentional contact of the v-cutter button or the backward/forward movement of the v-cutter due to the contact tunnel wall when pushing/pulling of the device.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: VIRTUOSAPH PLUS, WITH RADIAL
• Type of Device: LAPAROSCOPE, GENERAL
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 7355505
• MDR Text Key: 102996891
• Report Number: 1124841-2018-00046
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K160206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 77K
• Other Device ID Number: (01)00699753450769
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 04/05/2018
• Supplement Dates FDA Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention