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

Model Number VSP550EX

Device Problem Defective Device (2588)

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

Event Date 11/20/2023

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.For this reason, terumo references evaluation conclusion code 11.

Event Description

The user facility reported to terumo cardiovascular that during vein harvesting, the v-cutter does not work properly.There was a delay on the procedure, they did not changed out the unit; as it was converted to open surgical technique.As per subsidiary, the harvester (v-cutter) did not work properly, don¿t cut/cautery.The device was connected to valley lab force fx.They used a bipolar generator, set up as is describe in the ifu; macro in 16 watts.They modified the setting up to the potency of 18 watts, and reposition the v-utter several times onto the branch or touch the tunnel side.They also disconnect and reconnect the bipolar cord from the generator port.For spot cautery, they used the v-cautery switch outside of the patient but did not work.*the surgery was completed successfully with no blood loss and, patient effect.

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 12, 2023.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 213, 67).The affected sample was inspected upon receipt with no visual anomalies observed.The sample was electrically tested, and electrical resistances were found to be stable and within product specifications.As the event could not be replicated, a definitive root cause could not determined.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: douglas patton ; 125 blue ball road; elkton, MD 21921 ; 7346634145
• MDR Report Key: 18314147
• MDR Text Key: 330308224
• Report Number: 1124841-2023-00277
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00699753450769
• UDI-Public: (01)00699753450769
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K160206
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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: Other
• Device Model Number: VSP550EX
• Device Catalogue Number: N/A
• Device Lot Number: 25K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 01/02/2024
• Supplement Dates FDA Received: 01/19/2024
• 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): Required Intervention
• Patient Sex: Male