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

Catalog Number VC16

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 05/05/2014

Event Type  Other  

Event Description

Sorin group received a report that during a vein harvesting procedure, the jaws of the vascuclear precision bipolar broke into two pieces inside of a pt's leg.The clinician was able to recover the pieces by incision.There was no report of pt injury.

Manufacturer Narrative

The pt identifier was not provided.Sorin group received a report that during a vein harvesting procedure, the jaws of the vascuclear precision bipolar broke into two pieces inside of a pt's leg.The clinician was able to recover the pieces by incision.There was no report of pt injury.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 AND COAGULATION AND 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 ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3853766
• MDR Text Key: 17259750
• Report Number: 1718850-2014-00158
• 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: Other
• Type of Report: Initial
• Report Date: 05/05/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: VC16
• Device Lot Number: 1405500078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: 82 YR
• Patient Weight: 74