MAUDE Adverse Event Report: CONVERGENT LASER TECHNOLOGIES OPTILITE; SURGICAL LASER FIBER

Model Number	SMH1040F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2025 the customer emailed olympus surgical technologies and reported the laser fiber distal tip broke off and was removed from the patient.Olympus surgical technologies does not manufacture the subject device and notified the oem of the issue on (b)(6) 2025.The device was not returned for analysis.Additional information was requested but has not been provided.
Event or Problem Description
It was reported that during a procedure the laser fiber distal tip broke off inside the patient.The broken portion was subsequently removed from the patient.No adverse patient effects were reported.

• Brand Name: OPTILITE
• Common Device Name: SURGICAL LASER FIBER
• Manufacturer (Section D): CONVERGENT LASER TECHNOLOGIES; 1660 south loop road; alameda CA 94502
• Manufacturer (Section G): CONVERGENT LASER TECHNOLOGIES; 1660 south loop road; alameda CA 94502
• Manufacturer Contact: 1660 south loop road; alameda, CA 94502
• MDR Report Key: 23363444
• Report Number: 2938889-2025-00003
• Device Sequence Number: 21104852
• Product Code: GEX
• UDI-Device Identifier: 00855430006333
• UDI-Public: (01)00855430006333
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K951910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 09/06/2025
• Device Model Number: SMH1040F
• Device Lot Number: 22207315-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown