MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA 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	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom reported a faulty cutter during procedure.Additional information confirmed the cutter continued to aspirate while the fault occurred.There was no medical intervention required, no impact or injury to the patient.
Additional Manufacturer Narrative
The device was requested but has not yet been returned.Manufacturing and sterilization records were reviewed and found to be acceptable.This investigation is ongoing.
Additional Manufacturer Narrative
The device has been returned, but not evaluated yet.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.This investigation is ongoing.
Additional Manufacturer Narrative
Evaluation completed.Two 25ga bi-blade vit cutters were returned loose in a plastic bag.Cutter lot x2127, se5625b, is handwritten on the returned label.The tip protectors were not returned.Visual inspection found both of the cutters dirty with particulates and dried solutions all over and fluid in the tubing.Most of the tubing on one cutter had been cut off and was not returned.There was approximately 1.5 inches of tubing remaining attached to the back of the cutter.There was tape around the needle on this same cutter.The needle was bent.The second cutter needle was also bent.A functional test was performed using a stellaris elite system.The cutter did not cut.The inner needle was binding up and preventing cutting.It should be noted that a bent needle could contribute to poor cutting performance due to friction between the inner and out needle assemblies.Due to the returned condition, and evidence of use, the cause of the bent needles cannot be determined.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: 25 GA BI-BLADE VITRECTOMY CUTTER
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree ct. industrial blvd.; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree ct. industrial blvd.; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 17194267
• Report Number: 0001920664-2023-70062
• Device Sequence Number: 5680458
• 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,Followup
• Report Date (Section B): 05/05/2023

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; Not provided
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 08/03/2023; 08/30/2023
• 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
• Patient Sex: Unknown