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

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	07/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
The user facility in japan reported a vitrectomy cutter did not move.It is unknown if the aspiration function worked or not.The cutter was replaced with another one and the procedure was completed without any patient injuries.
Additional Manufacturer Narrative
Evaluation completed.One opened se5625b pouch from lot x1940 was returned.Visual inspection found the tip protector was in place, as it should be.There was dried solution visible in the tubing.The needle was not bent.The port window was clogged with what looks like dried blood and organic material.The tubing and connectors were inspected and no damage was found.A functional test was performed using a stellaris elite system.The cutter cannot cut or aspirate in this condition.Due to evidence of use, the cause of the clog cannot be determined.
Additional Manufacturer Narrative
The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.

• Brand Name: STELLARIS ELITE 25G BI-BLADE VITRECTOMY
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 17444603
• Report Number: 0001920664-2023-70077
• Device Sequence Number: 2711795
• Product Code: HQC
• UDI-Device Identifier: 00757770059737
• UDI-Public: (01)00757770059737(17)231107(10)X1940
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 07/13/2023

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: 11/07/2023
• Device Model Number: SE5625B
• Device Lot Number: X1940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; Not provided
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/19/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown