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

Catalog Number VC15

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2014

Event Type  Other  

Event Description

Sorin group received a report that the upper jaw of a vascular precision bipolar broke during a vein harvesting procedure.The jaw did not completely break off.There was no report of patient injury.

Manufacturer Narrative

Sorin group received a report that the upper jaw of a vascuclear precision bipolar broke but did not completely separate during a vein harvesting procedure.There was no report of patient injury.The involved device was returned to sorin group usa for evaluation.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: VASCUCLEAR PRECISION BIPOLAR
• Type of Device: ELECTROSURGICAL CUTTING & 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, manager ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3955646
• MDR Text Key: 4621791
• Report Number: 1718850-2014-00233
• 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: Initial
• Report Date: 06/20/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: VC15
• Device Lot Number: 1410500057
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2014
• 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: 83 YR
• Patient Weight: 90