MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE 25G BI-BLADE VITRECTOMY CUTTER; 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	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom reported the cutter was not cutting efficiently from the beginning of surgery.The aspiration was still working according to the surgeon.Once the cutter was changed, everything was fine.There was no patient impact nor medical intervention required.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
The evaluation has been completed.One opened se5625b pouch from lot x2127 was returned.The expiration date on the label was 2023-dec-05.The pouch contained one 25ga bi-blade vitrectomy cutter.The assembly was dirty with dried solutions and particulates all over the outer needle shaft and port area.The assembly appeared used.The tip protector was not received.The needle was bent at the base and near the tip of the handpiece.The port window was in the opened position.The back cap was correctly positioned with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris elite system.The cutter did not cut.The cutter had good aspiration and was not blocked.It should be noted that a bent needle could contribute to poor cutting performance.Due to the returned condition, being loose in the pouch with no tip protector, the root cause of the bent needle cannot be determined.Manufacturing and sterilization records for se5625b, lot x2127 were reviewed and found to be acceptable.This investigation is complete.

• Brand Name: STELLARIS ELITE 25G BI-BLADE VITRECTOMY CUTTER
• 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: 18142123
• Report Number: 0001920664-2023-70124
• Device Sequence Number: 12773830
• Product Code: HQC
• UDI-Device Identifier: 00757770059737
• UDI-Public: (01)00757770059737(17)231205
• 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): 10/24/2023

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?: 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
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT.
• Patient Sex: Unknown