MAUDE Adverse Event Report: ALCON LABORATORIES, INC. ULTRAVIT VITRECTOMY PROBE; PROBE, VITRECTOMY

Model Number	8065751700
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Staff reported that a constellation 27+ ultravit handpiece was not working properly.The surgeon noted that the handpiece was suctioning without the footpedal being depressed.A new handpiece was used to complete the procedure as planned and no harm came to the patient.The handpiece was saved for clinical engineering and will be returned to the manufacturer for failure analysis.

• Brand Name: ULTRAVIT VITRECTOMY PROBE
• Common Device Name: PROBE, VITRECTOMY
• Manufacturer (Section D): ALCON LABORATORIES, INC.; 6201 south freeway; fort worth TX 76134
• MDR Report Key: 7792625
• Report Number: 7792625
• Device Sequence Number: 11140566
• Product Code: MLZ
• UDI-Device Identifier: 00380657517008
• UDI-Public: (01)00380657517008
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2018
• Report Date (Section F): 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8065751700
• Device Catalogue Number: 8065751700
• Device Lot Number: 1949889H
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 97
• Date Report Sent to FDA: 08/15/2018