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

Catalog Number VC17

Device Problems Smoking (1585); Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2015

Event Type  Other  

Manufacturer Narrative

The patient identifier was not provided.Sorin group received a report that the bipolar smoked during the vein harvesting procedure.No adverse effects were detected with the patient.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the bipolar smoked during the vein harvesting procedure.No adverse effects were detected with the patient.

Manufacturer Narrative

Sorin group received a report that the bipolar smoked during the vein harvesting procedure.No adverse effects were detected with the patient.One evh bipolar device was returned to sorin group usa for evaluation.A visual inspection did not identify any defects in the returned device.No traces of charring, melting or overheating of the device were discovered.The returned unit and a unit pulled from inventory were functionally tested and the issue could not be reproduced.Testing found that the complaint device functioned identically to the unit pulled from inventory.No smoke or fire could be generated when following the ifu.However, steam was generated during testing, which is expected.The ifu recommends generator settings and wattages to be used depending on the generator that is available.Additionally, the ifu recommends activation in three second intervals.It is possible to generate smoke if the device is used contrary to the ifu.As the issue could not be reproduced during testing, no root cause could be determined and corrective actions were not identified.Sorin group will monitor the market for trends related to this type of issue.

• Brand Name: VASCUCLEAR PRECISION BIPOLAR
• Type of Device: ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP USA; 14401 w. 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5001258
• MDR Text Key: 24584741
• Report Number: 1718850-2015-00272
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102983
• 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: Followup
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: VC17
• Device Lot Number: 1414700079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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 Age: 73 YR
• Patient Weight: 71