MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO VH HANDPIECE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VSP550EX

Device Problem Failure to Cut (2587)

Patient Problem No Code Available (3191)

Event Date 08/17/2020

Event Type  malfunction  

Event Description

The terumo evh handpiece not working correctly to harvest saphenous vein endoscopically.I had to make multiple incisions on patient's leg to harvest the vein.Terumo virtuosaph plus endoscopic vessel harvesting system connected to olympus coagulation unit would not cut or coag with bipolar.Fda safety report id# (b)(4).

• Brand Name: TERUMO VH HANDPIECE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
• MDR Report Key: 10430791
• MDR Text Key: 203823212
• Report Number: MW5096141
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/17/2020

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: 10/31/2022
• Device Model Number: VSP550EX
• Device Lot Number: 9YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 78