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

Model Number VSP550EX

Device Problems Thermal Decomposition of Device (1071); Defective Component (2292)

Patient Problem Injury (2348)

Event Date 07/30/2019

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 procedure, while using the vsp device, it was found to be charred.Product was changed out.Procedure was completed successfully.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.The affected sample that was returned was the harvester, not the dissector as originally reported.The affected sample was inspected upon return.It was observed that the end of the v-cutter was broken.There was charring of blood on the electrodes within the v-cutter.A representative retention sample was inspected with no physical or electrical anomalies noted.During the manufacturing process, all vsp550 are thoroughly inspected and tested for functionality and performance along with inspection for v-cutter mechanism, prior to packaging.The most likely root cause of this event is excessive bending force being applied to the v-cutter causing the breakage and allowing the electrodes to be directly exposed to blood.The blood charred on the v-cutter due to heat and electrical conductivity.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

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 august 20, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (device availability - added date returned to manufacturer).(updated establishment name).(date received by manufacturer).(indication that this is a follow-up report).(follow-up due to correction and additional information).(device evaluation anticipated by manufacturer).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions.) 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 8910445
• MDR Text Key: 154880051
• Report Number: 1124841-2019-00228
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 8XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 08/20/2019; 09/17/2019
• Supplement Dates FDA Received: 09/06/2019; 09/18/2019
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other