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

Model Number	840-411
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation after connecting the device to the host, the fiber had no energy.The procedure was completed with another fiber with no patient complications.Analysis of the returned fiber identified an internal connector fracture.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The fiber device received in one piece and no defects to the fiber body.The tip was in good condition; however, an internal connector fracture was identified and no aim beam.There was no light exiting face.A review of the device instructions for use (ifu) was completed.The ifu states: inspect the fiber for kinks, punctures, fractures, or other damage.If the fiber appears damaged, do not use the fiber; return it to the supplier for replacement.There is no indication that the device was not used in accordance with the ifu.Based on the information available, boston scientific concludes that the reported fiber not working was confirmed.This condition of distorted light exiting the connector can be a result of an internal connector fracture.Fracture within the connector can occur during procedural handling of the fiber during setup or use.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.In addition, the interaction of internal connector fracture and console may have led to overheating causing the burn marks on connector face.Based on analysis result, the investigation conclusion code assigned is cause traced to component failure which indicates, expected or random component failure without any design or manufacturing issue.

• 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: 20707900
• Report Number: 2124215-2024-72315
• Device Sequence Number: 18195550
• 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
• Report Date (Section B): 11/18/2024

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
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/18/2024
• 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: 51 YR
• Patient Sex: Female
• Patient Weight: 65 KG