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

Catalog Number	VC15
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Sorin group received a report that a piece of a blade guard in the vascuclear precision bipolar kit broke off inside the leg of the patient during a procedure.The piece was recovered without patient injury and the kit was switched out.The device has been requested for return to sorin group usa for evaluation.A follow-up report will be submitted when the investigation is complete.
Event or Problem Description
Sorin group received a report that a piece of a blade guard in the vascuclear precision bipolar kit broke off inside the leg of the patient during a procedure.The piece was recovered without patient injury and the kit was switched out.
Additional Manufacturer Narrative
The device was returned to sorin group usa for investigation.Visual inspection of the returned device confirmed the reported damage.Sorin group concluded that the damage was caused by excessive counter-clockwise torsion of the device while the jaws were in the open position, evidenced by the diagonal nature of the fractured blade guard.Applying torque to the device while the jaws are open is contraindicated in the instructions for use (ifu).The ifu states "do not advance or torque the instrument with the jaws open or use the jaws for spread dissection.These actions will damage the instrument." there was no patient injury or device malfunction.Sorin group issued a capa to further investigate broken jaw concerns.The capa is closed, pending effectiveness verification.The new bipolar design will incorporate a higher molecular weight polycarbonate material for the jaws and a new, refined jaw mold.No capa addendum is needed.A review of the device history record did not identify any deviations or non-conformities relevant to the reported issue.Sorin group will continue to monitor for effectiveness of the capa actions.

• Brand Name: VASCUCLEAR PRECISION BIPOLAR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SORIN GROUP USA, INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 5901480
• Report Number: 1718850-2016-00388
• Device Sequence Number: 16287932
• Product Code: GEI
• UDI-Device Identifier: 00803622132360
• UDI-Public: 00803622132360
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K102983
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2016

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: 10/31/2018
• Device Catalogue Number: VC15
• Device Lot Number: 1528000001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2016
• Supplement Report FDA Received Date: 11/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1