MAUDE Adverse Event Report: SORIN GROUP USA, INC. VASCUCLEAR PRECISION BIPOLAR; ELECTROSURGICAL, CUTTING AND COAGULATION AND 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 05/18/2015

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that the clinician found debris attached to the vein when it was removed from the harvesting site.There was no other debris found.There was no pt injury.

Manufacturer Narrative

Lot number: the lot number was not provided.Therefore the expiration date is unk.Manufacture date: the lot number was not provided.Therefore the manufacture date is unk.Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the clinician found debris attached to the vein when it was removed from the harvesting site.There was no other debris found.There was no pt injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group received a report that the clinician found debris attached to the vein when it was removed from the harvesting site.There was no other debris found.There was no patient injury.The involved vascular precision bipolar was discarded before sorin group usa was made aware of the event, so nothing was returned for evaluation.The lot number was also not reported, so a review of the dhr was not possible.Without the ability to reproduce or verify the reported issue, the root cause could not be determined and no corrective actions could be identified.No trend has been identified.Sorin group will continue to monitor the market for trends related to this issue.Device discarded before sorin made aware.

• 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 w 65th way; arvada CO 80004
• Manufacturer Contact: carrie wood ; 14401 w 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 4845132
• MDR Text Key: 17305727
• Report Number: 1718850-2015-00177
• 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,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VC15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Other