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

Model Number	VC17
Health Effect - Clinical Codes	Burn(s) (1757); Injury (2348)
Date of Event	06/13/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: VEIN HARVESTING SYSTEM
• Manufacturer (Section D): AESCULAP AG/SORIN; am aesculap-platz 78532; tuttlingen ; GM
• MDR Report Key: 6728341
• Report Number: MW5071103
• Device Sequence Number: 1243186
• Product Code: GCJ
• UDI-Device Identifier: 00803622132384
• UDI-Public: (01)00803622132384
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR