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

Model Number VSP550EX

Device Problem Failure to Cut (2587)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 08/17/2020

Event Type  Injury  

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.For this reason, terumo references evaluation conclusion code.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during vein harvesting, the harvester was unable to cut.Per user facility, the side branches would not seal with coagulant.There was bleeding in the tunnel.The arterial branch would not seal and had to open the leg.There was 200ml of blood loss.The product was changed out.The surgery 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 september 4, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 11, 3331, 3259, 19).Method code #1: 10 - testing of actual/suspected device.Method code #2: 11 - testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 - analysis of production records.Results code#: 3259 - improper physical structure.Conclusions code: 19 - cause traced to user.The affected sample was inspected and confirmed to have a broken v-cutter area allowing for blood to reach the electrical path and become burned.A representative retention sample was reviewed and inspected for any signs of damage or anomalies.The sample was inspected for electrical integrity.No anomalies were observed and electrical values were within specification.During the manufacturing process, all vsp550 are visually inspected and tested for functionality and performance along with inspection for v-cutter mechanism, prior to packaging.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Event Description

As per user facility, they tried to troubleshoot the device and the generator, neither corrected the problem.

• 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: 10493027
• MDR Text Key: 205671614
• Report Number: 1124841-2020-00208
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769
• 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: 10/20/2020

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: 10/31/2022
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 9YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS VES 40 SUING MASTER; OLYMPUS VES 40 SUING MASTER
• Patient Outcome(s): Other