MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP VIRTUOSAPH ENDOSCOPIC VEIN HARVESTING SYSTEM; ENDOSCOPIC VEIN HARVESTER

Catalog Number MCVS550

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2016

Event Type  malfunction  

Event Description

As the pa (physician assistant) was dissecting the vein using the terumo endoscopic vein harvest system ref# mcvs550 and lot# 57k and exp.8/2018, it was noted that the "locking shaft" on the bipolar dissector was disconnected, which is not normal.The system was subsequently removed from the patient and a new system opened.No injury was noted by the p.A.To the patient, other than a slight delay caused by opening a new system.Both the bipolar dissector and the cone dissector (the entire package contents) were saved, along with the outer packaging, and sent to biomed for further evaluation.Manufacturer response for vein harvesting system, virtuosaph vein harvesting (per site reporter): none.

• Brand Name: VIRTUOSAPH ENDOSCOPIC VEIN HARVESTING SYSTEM
• Type of Device: ENDOSCOPIC VEIN HARVESTER
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP; 125 blue ball road; elkton MD 21921
• MDR Report Key: 5662266
• MDR Text Key: 45379022
• Report Number: 5662266
• Device Sequence Number: 1
• Product Code: OSV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: MCVS550
• Device Lot Number: 57K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/04/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR