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

Model Number VSP550EX

Device Problem Thermal Decomposition of Device (1071)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

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.(b)(4).

Event Description

The user facility reported to terumo cardiovascular that during vein harvesting, there was a burnt mark that was seen on the tip of the harvester.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 december 22, 2020.Upon further investigation of the reported event, the following information is new and/or changed: identification of evaluation codes 3123, 4614, 4582, 1071, 10, 11, 3331, 642, 19.Component code: 3123 - tip.Health effect - impact code: 4614 - serious injury/ illness/ impairment, health effect - clinical code: 4582 - no clinical signs, symptoms or conditions, medical device problem code: 1071 - thermal decomposition of device, type of investigation #1:10 - testing of actual/suspected device, type of investigation #2: 11 - testing of device from same lot/batch retained by manufacturer, type of investigation #3: 3331 - analysis of production records, investigation findings: 642 - thermal problem, investigation conclusions: 19 - cause traced to user.The affected sample was inspected upon receipt and confirmed to have burn marks and a hole in the v-cutter.A representative retention sample was reviewed and electrically tested with no anomalies and all electrical tests within specification.The v-cutter on the retention sample was fully intact.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.Based on review of past complaints, the cracked/fractured distal end of the v-cutter most likely resulted from excessive force applied to the distal end of the v-cutter during the procedure.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: 11055793
• MDR Text Key: 223147877
• Report Number: 1124841-2020-00290
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 01K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS GENERATOR AT 8 WATTS; OLYMPUS GENERATOR AT 8 WATTS
• Patient Outcome(s): Other