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 No Consequences Or Impact To Patient (2199)

Event Date 06/06/2017

Event Type  malfunction  

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 Description

The user facility reported to terumo cardiovascular that during vein harvesting procedure, the wiper had a malfunction, according to the surgeon.No consequence or impact to the patient.Product was changed out.Procedure 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 june 6, 2017.Upon further investigation of the reported event, the following information is new and/or changed: (b)(4).The returned sample was visually inspected.It was noted that the wiper did not move on the endoscope when the two devices were connected together.The wiper ring was dismantled, and it was found that the fixed part for the wiper rod in the n wiper base was broken.It was confirmed that the wiper wouldn't function when the wiper rod was dislodged from the n wiper base.All wipers undergo inspection for operational performance and function during the manufacturing process; therefore, it is likely that the fixed part of the wiper was damaged during shipping or handling.A possible cause for this damage is that if foreign matter adhered with the wiper in the distal end of the device, and the wiper was forcibly actuated multiple times with excessive force, the wiper rod hitting into the fixed part of the n wiper base may have caused it to dislodge from the n wiper base.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 Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6672362
• MDR Text Key: 78587505
• Report Number: 1124841-2017-00115
• Device Sequence Number: 1
• Product Code: GCJ
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 6YK
• Other Device ID Number: (01)00699753450769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 06/27/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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