MAUDE Adverse Event Report: AESCULAP AG/SORIN SORIN ENDOSCOPIC VESSEL HARVESTING KIT; VEIN HARVESTING SYSTEM

Model Number VC17

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 06/13/2017

Event Type  Injury  

Event Description

While harvesting endoscopic vein from the left leg and while surgeon was working the light inside, the trocar blistered the left leg in 3 areas.Zeroform was applied to the left leg and wrapped with kerlix and ace.Wound nurse will be looking at wounds the day following the procedure and after 48 hours of wrapping to prevent hematoma per protocol.Follow-up to be documented in emr.Presently the patient is doing well.Sorin vascular endoscopic vessel harvesting kit was also used with another sorin product called precision bipolar, cat.Reference #pbdo2, lot 1525100193 due to expire in september 2018.All like products were pulled from stock.Investigation per fda other medwatch reports with this device were found in fda archives from a few years ago - see link below: https://archive-it.Org/collections/7993?show-archivedpages&all=&exact=vein+harvesting&none=&host=&hitsperdupe-0&mimetype-0&month0-&year0=&month1=&year1=&search=advanced+search.Complications of surgery/procedure: surgery/procedure name: cabg.Complication: accidental injury, i.E.Perforation/laceration harm - temporary - intervention required.

• Brand Name: SORIN ENDOSCOPIC VESSEL HARVESTING KIT
• Type of Device: VEIN HARVESTING SYSTEM
• Manufacturer (Section D): AESCULAP AG/SORIN; am aesculap-platz 78532; tuttlingen ; GM
• MDR Report Key: 6728341
• MDR Text Key: 80758738
• Report Number: MW5071103
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00803622132384
• UDI-Public: (01)00803622132384
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2017

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: 09/01/2018
• Device Model Number: VC17
• Device Catalogue Number: VC17
• Device Lot Number: 1707900211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 42 YR