MAUDE Adverse Event Report: BAUSCH + LOMB STIFF 25GA SHIELDED WIDE; ENDOILLUMINATOR

Model Number	56.21.25PS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned for evaluation, but the investigation has not begun.This investigation is ongoing.
Event or Problem Description
A user facility reported that while utilizing a synergetics light probe on a constellation, the fiber optic cable separated from the metal sheath.The sheath stayed in the trocar and did not touch the retina.The piece that broke off was removed with a forceps from the patient's eye without harm.The surgery was delayed for 10 minutes.
Additional Manufacturer Narrative
The product was received for evaluation.The shaft has broken off at the stiffener bushing.Metal shaft has evidence of "bend" stressing.One side of the broken area has evidence of stretching and the opposite side has compression or bulging along with visible stress marks.The probe appears to have been exposed to radial stresses that exceeded the strength of the shaft.The device history record was reviewed and found no nonconformities or anomalies related to this complaint.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.The investigation is complete.
Additional Manufacturer Narrative
Correction d.4.(b)(4).

• Brand Name: STIFF 25GA SHIELDED WIDE
• Common Device Name: ENDOILLUMINATOR
• 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 ; 3845 corporate centre dr.; o'fallon, MO 63368 ; 636226-3220
• MDR Report Key: 19624216
• Report Number: 0001932402-2024-00004
• Device Sequence Number: 6334784
• Product Code: MPA
• UDI-Device Identifier: 20841305107322
• UDI-Public: (01)20841305107322(17)261002(10)M0050892
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K952586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2024

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: 10/02/2026
• Device Model Number: 56.21.25PS
• Device Lot Number: M0050892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 07/19/2024; 11/09/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/12/2024; 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown