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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA, INC. VASCUCLEAR PROCISION BIPOLAR; ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES
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SORIN GROUP USA, INC. VASCUCLEAR PROCISION BIPOLAR; ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES Back to Search Results
Catalog Number VC15
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)
Event Type  Other  
Event Description
Sorin group received a report of multiple occurrences where the camera and scope slipped out of the optical dissector during a vessel harvesting procedure.It was also reported that each occurrence resulted in damage only to the vessel being harvested.There was no report of injury to the pt.
 
Manufacturer Narrative
The devices were returned to sorin group usa for eval.The investigation is on going.A follow up report will be sent when the investigation is complete.
 
Manufacturer Narrative
Sorin group received a report of multiple occurrences where the camera and scope slipped out of the optical dissector during a vessel harvesting procedure.It was also reported that each occurrence resulted in damage only to the vessel being harvested.There was no report of injury to the patient.A sorin group procedural specialist was dispatched to the facility to investigate.While at the facility, the procedural specialist learned that the facility had recently started using a new endoscope with a 1cm longer shaft than the endoscope used previously.The specialist indicated that the new scope did not seem to seat fully into the optical dissector when inserted.One vascuclear optical dissector was returned to sorin group usa for further investigation and an additional unit from lot 1330100181 was pulled from inventory for comparison.A visual inspection and functional evaluation of the returned unit and the unit from inventory, including a removal force test, revealed that the force required to remove an endoscope with a 30cm shaft was significantly lower than that for an endoscope with a 29cm shaft.A review of the validation documentation for this device found that all qualifications pertaining to the device's ability to retain the endoscope were performed using a fixture with a shaft length of approximately 29.3cm.The instructions for use for this device had previously indicated that the instrument was compatible with a shaft length of 290mm to 300mm.As a correction, the ifu has been updated to indicate that the device is only compatible with a shaft length of 290+/- 3mm.A capa (b)(4) has also been initiated at sorin group usa to confirm the root cause of this issue.
 
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Brand Name
VASCUCLEAR PROCISION 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 Key4129351
MDR Text Key20297163
Report Number1718850-2014-00332
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102983
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Physician Assistant
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date07/31/2017
Device Catalogue NumberVC15
Device Lot Number1418900029
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/22/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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