MAUDE Adverse Event Report: CONVERGENT LASER TECHNOLOGIES OPTILITE; POWERED LASER SURGICAL INSTRUMENT

Model Number	CGH1080F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Fiber did not operate at surgical site, no smoke present, no spark present, no flame present.The fiber appeared not to be intact within the laser fiber sheath when initially turned on during use, light visualized in the fiber sheath, laser operator discontinued use, disconnected from laser and replaced, weak aiming beam.

• Brand Name: OPTILITE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): CONVERGENT LASER TECHNOLOGIES; 1660 south loop road; alameda CA 94502
• MDR Report Key: 20852402
• Report Number: 20852402
• Device Sequence Number: 8039625
• Product Code: GEX
• UDI-Device Identifier: 00855430006036
• UDI-Public: (01)00855430006036(11)230206(17)260206(10)21570
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024
• Report Date (Section F): 12/03/2024

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: Other
• Device Model Number: CGH1080F
• Device Lot Number: 21570
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2024
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Date Report Sent to FDA: 12/03/2024