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

Model Number N/A

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group usa manufactures the vascular precision bipolar.The incident occurred in (b)(6).Sorin group received a report that during the procedure the tip of the vascular precision bipolar broke off inside the patient's leg.The tip was completely retrieved from the patient's leg, and there were no complications.There was no report of patient injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that during the procedure the tip of the vascular precision bipolar broke off inside the patient's leg.The tip was completely retrieved from the patient's leg, and there were no complications.There was no report of patient injury.

Manufacturer Narrative

Sorin group received a report that during the procedure the tip of the vascular precision bipolar broke off inside the patient's leg.The tip was completely retrieved from the patient's leg, and there were no complications.There was no report of patient injury.One vascular precision bipolar device was returned to sorin group usa for further investigation.The device was subjected to visual inspection which confirmed the user report that the upper jaw had broken off.The angle of the break suggests that the jaw was broken off from being forced backwards towards the proximal end of the bipolar device.Based on the results of the evaluation of the returned device, it has been concluded that the issue was likely the result of advancing the bipolar with the jaws in the open position, contrary to the ifu.The vascular precision bipolar instructions for use states: "caution: do not advance or torque the instrument with the jaws open or use the jaws for spread dissection.These actions will damage the instrument." this is a known issue caused due to improper handling of the evh device.

• Brand Name: VASCULAR PRECISION BIPOLAR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SORIN GROUP USA; 14401 w. 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: 5171760
• MDR Text Key: 29342990
• Report Number: 1718850-2015-00446
• Device Sequence Number: 1
• Product Code: NUJ
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: VC16
• Device Lot Number: 1508500005
• 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: 04/15/2015
• 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: 80