MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE 25G BI-BLADE VITRECTOMY CUTTER; UNIT, PHACOFRAGMENTATION

Model Number	SE5625B
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom stated that during surgery the vitrectomy cutter stopped, and aspiration continued.There was a delay in surgery of about 0-15 minutes.The surgery was completed and there was no patient injury.The patient's current status is reported as stable.This report is for the first cutter.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
A plastic bag with an esa hub, sleeve assemblies, and esa infusion cannulas were received.The vitrectomy cutter was not returned.Therefore, we are unable to investigate further for root cause.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.We will continue to monitor for the reported complaint.No corrective action required.

• Brand Name: STELLARIS ELITE 25G BI-BLADE VITRECTOMY CUTTER
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 3365 treecourt industrial blvd; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 16936256
• Report Number: 0001920664-2023-70050
• Device Sequence Number: 5830415
• Product Code: HQC
• UDI-Device Identifier: 00757770059737
• UDI-Public: (01)00757770059737(17)231205(10)X2127
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2023

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: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: SE5625B
• Device Lot Number: X2127
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown