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

Model Number VSP550EX

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

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, the customer was unable to cauterize.The saphenous vein was eventually harvested via open cut-down approach due to product issue.Product was 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 january 29, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315) type of investigation code #1: 11 - testing of device from same lot/batch retained by manufactur type of investigation code #2: 3331 - analysis of production records type of investigation code #3: 4114 - device not returned results code: 3221 - no findings available conclusions code: 4315 - cause not established the affected sample was not returned so a thorough investigation could not be conducted.The reported issues were not able to be replicated within the retention sample; therefore, the root cause for this event cannot be determined.During the manufacturing process, the v-cutter mechanism is 100% inspected and tested for functionality and performance prior to packaging.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: 11252483
• MDR Text Key: 229584226
• Report Number: 1124841-2021-00012
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 03K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OLYMPUS GENERATOR
• Patient Outcome(s): Other