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

Model Number	840-411
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during a procedure to remove a urethral stone, the fiber was overheating; it was too hot to touch.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 glass tip was degraded down to the fiber jacket.The laser fibers are consumable devices and expected to degrade with use.It was also noted that the fiber jacket has burn marks and melting.Additionally, the light from sma connector was bright and round indicating that there was no fracture within the sma connector.However, the connector face has burn marks on it and this confirms the reported event.The device instructions for use (ifu) indicates that the ifu contains appropriate instructions and warnings for use.Procedural conditions, such as physician technique, size and composition of the material being ablated, may have contributed to the heavy degradation, burn marks and melting on the fiber jacket and ultimately the burn marks observed on the connector face.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.Do not exceed the recommended maximum power levels associated with the selected fiber size and in the event of reduced or no laser energy output during application the fiber connector may be hot to touch.The ifu instructs the user to carefully inspect the fiber for kinks, punctures, fractures, broken ball tip, 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 procedure to remove a urethral stone, the fiber was overheating; it was too hot to touch.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: 18157066
• Report Number: 2124215-2023-63635
• Device Sequence Number: 17782079
• 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
• Report Date (Section B): 01/29/2024

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: 08/17/2024
• Device Model Number: 840-411
• Device Catalogue Number: 840-411
• Device Lot Number: 0000011491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 80 KG