MAUDE Adverse Event Report: GYRUS ACMI, INC. SOLTIVE PRO SUPERPULSED LASER SYSTEM; POWERED LASER SURGICAL INSTRUMENT

Model Number	TFL-SLS
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the laser fiber that this fiber caught on fire at the connect ion point.The customer put the laser on standby and stopped the fire.There were no reports of harm.This event includes two (2) reports.Report with patient identifier (b)(6), laser system model tfl-pls , serial number is not known.Report with patient identifier (b)(6), ball tip single use fiber- tfl-fbx200bs, lot kr262865.This report being submitted is for report with patient (b)(6), laser system model tfl-pls , serial number is not known.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation and follow up with the user facility is currently being performed.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a definitive root cause could not be established.Per due diligence logs, three attempts were performed to contact to the customer for device retrieval and information, there was no response.At the moment, there shall be no device returned for evaluation.If the device or additional information were to become available at a later date, the complaint shall be updated appropriately.The probable cause of the fiber catching fire at the connector could therefore not be determined.Per soltive laser system instructions for use (ifu): "any tampering with the laser fiber contact connector may cause unwanted emission of laser radiation.Before performing any laser emission, make sure that the probe is inserted correctly.Pay attention to the firing direction." olympus will continue to monitor field performance for this device.

• Brand Name: SOLTIVE PRO SUPERPULSED LASER SYSTEM
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17733214
• Report Number: 3003790304-2023-00363
• Device Sequence Number: 17611167
• Product Code: GEX
• UDI-Device Identifier: 00821925044135
• UDI-Public: 00821925044135
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K183647
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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 Model Number: TFL-SLS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown