MAUDE Adverse Event Report: COHERENT ACCUTRAC; POWERED LASER SURGICAL INSTRUMENT

Model Number	840-411
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure the fiber could not work and felt hot.The procedure was completed with another fiber with no patient complications were reported.
Event or Problem Description
It was reported that during a ureteroscopic holmium laser lithotripsy procedure the fiber could not work and felt hot.The procedure was completed with another fiber.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The fiber device received in one piece; fiber body no defects.During the product analysis, the exposed tip was degraded.The laser fibers are consumable devices and expected to degrade with use.Additionally, there was no light exiting the connector face, indicating that there was a fracture within the sma connector, this confirms the reported event.The device instructions for use (ifu) indicates that the ifu contains appropriate instructions and warnings for use.A fracture within the sma connector can occur during procedural handling of the fiber like setup or use.The fiber connector may have a developed a microfracture that with use or handling can become larger resulting in an insufficient aiming beam and low laser energy output.In this case the interaction between the fracture connector and console may have led to connector overheating causing the fiber to feel hot as the event stated.Finally, improper use of the device or use of a damaged device may result in severe eye or tissue damage, fire in the treatment room and accidental laser exposure to the treatment room personnel or patient.The ifu instructs the user to carefully inspect the fiber for kinks, punctures, fractures or other damage.If the fiber appears damaged, do not use the device.Return it to boston scientific for replacement.Based on analysis result, the investigation conclusion code assigned is cause traced to component failure.
Event or Problem Description
It was reported that during a ureteroscopic holmium laser lithotripsy procedure the fiber could not work and felt hot.The procedure was completed with another fiber.No patient complications were reported.

• Brand Name: ACCUTRAC
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): COHERENT; 32 hampshire rd; salem NH 03079
• Manufacturer (Section G): COHERENT INCORPORATED; 5100 patrick henry drive; santa clara CA 95054
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18316013
• Report Number: 2124215-2023-70418
• Device Sequence Number: 6784049
• Product Code: GEX
• UDI-Device Identifier: 08714729802716
• UDI-Public: 08714729802716
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2024

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: 08/25/2024
• Device Model Number: 840-411
• Device Catalogue Number: 840-411
• Device Lot Number: 0000011515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 01/25/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/02/2024; 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 78 KG