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

Model Number	SMH1060F
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during laser irradiation the fiber broke and caused a minor finger injury to the physician.Pain was brief; no treatment or infection reported.
Additional Manufacturer Narrative
The manufacturer received a complaint from its japanese distributor, (b)(6) hospital supply co., on september 11, 2025 regarding an event that occurred on september 27, 2024.During laser irradiation, the disposable laser fiber reportedly broke approximately 15 inches proximal to the distal tip, resulting in a minor finger injury to the operating physician.The injury caused brief pain, required no medical intervention, and resolved without complication.Examination of the returned fiber showed no evidence of thermal, optical, or material degradation, and no laser-induced or thermal damage.The fracture site was located in a section of the fiber frequently bent during use.The findings are consistent with mechanical overstress from sharp bending during clinical handling, rather than any manufacturing or material defect.The device functioned as designed, and no corrective actions to design or manufacturing are required.Because a similar break could potentially cause a more serious injury if it recurred, this report is being submitted on a voluntary basis.The report is submitted outside the standard timeframe because the manufacturer was not notified of the event until september 11, 2025, due to late communication from the distributor.A capa has been opened to reinforce reporting timelines and retrain (b)(6) hospital supply co.On prompt complaint escalation.Conclusion: the investigation confirmed that the fiber met design and manufacturing specifications.The failure was due to excessive bending during use.No manufacturing or material nonconformities were identified, and the risk to patients and users remains within acceptable limits when used per instructions.

• 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 ; 5108322130
• MDR Report Key: 23528584
• Report Number: 2938889-2025-00004
• Device Sequence Number: 10201997
• Product Code: GEX
• UDI-Device Identifier: 00855430006340
• UDI-Public: (01)00855430006340
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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 Model Number: SMH1060F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown