MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	BL5425V
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation completed.One 25ga vitrectomy cutter was returned pushed up into the finger of a blue surgical glove.The glove and a bl5425v pack label from lot v7875 were inside a plastic zip lock bag.The cutter's tip protector was not returned.The needle was bent.The port window was in the opened position.There was fluid in the lines.The back cap was aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no defects were found.A functional test was performed using a stellaris pc system.The inner needle only advances to approximately the center of the port, never reaching the cutting edge.The cutter cannot cut.It should be noted that a bent needle could contribute to poor cutting performance due to binding between the inner and out needle assemblies.The cause of the bent needle cannot be determined.The sterilization and lot history records were reviewed and found to be acceptable.
Event or Problem Description
During the procedure the victrector stopped cutting, but the aspiration continued.They opened a backup pack and continued with the surgery with no issue.

• Brand Name: STELLARIS PC VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• MDR Report Key: 6312339
• Report Number: 0001920664-2017-00045
• Device Sequence Number: 475335
• Product Code: HQC
• UDI-Device Identifier: 00757770058600
• UDI-Public: (01)00757770058600(17)180207
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2017

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: Physician
• Device Expiration Date: 02/07/2018
• Device Model Number: BL5425V
• Device Lot Number: V7875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1