MAUDE Adverse Event Report: SORIN GROUP USA, INC. VASCUCLEAR PRECISION BIPOLAR; ELECTROSURGICAL, CUTTING AND COAGULATION, ACCESSORIES

Catalog Number VC15

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Type  Other  

Event Description

Sorin group received a report of multiple occurrences where the camera and scope slipped out of the optical dissector during a vessel harvesting procedure.It was also reported that each occurrence resulted in damage only to the vessel being harvested.There was no report of injury to the pt.

Manufacturer Narrative

The devices were returned to sorin group usa for eval.The investigation is on going.A follow up report will be sent when the investigation is complete.

• Brand Name: VASCUCLEAR PRECISION BIPOLAR
• Type of Device: ELECTROSURGICAL, CUTTING AND COAGULATION, ACCESSORIES
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer Contact: cheri voorhees, mgr, quliaty ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4129327
• MDR Text Key: 4796563
• Report Number: 1718850-2014-00334
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician Assistant
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: VC15
• Device Lot Number: 1331500073
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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): Other