MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUTRAC; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068404110
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an accutrac 200 laser fiber was used during a ureteral flexible lithotripsy to treat calculus of the kidney on (b)(6) 2021.The laser console used during the procedure was a holmium laser.During the procedure, after 10 to 20 minutes of use, the accutrac laser fiber connector became hot and burned the physician.The physician received a minor burn and no treatment was required.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an accutrac laser fiber was used during a ureteral flexible lithotripsy to treat calculus of the kidney on (b)(6) 2021.The laser console used during the procedure was a holmium laser.During the procedure, after 10 to 20 minutes of use, the accutrac laser fiber connector became hot and burned the physician.The physician received a minor burn and no treatment was required.The procedure was completed with another accumax laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a1005 captures the reportable event of fiber overheated.Block h10: investigation analysis the returned accutrac laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured 243.7 cm from the end of the connector to the end of the fiber body.Functional analysis revealed that there was distorted light from the sma connector, indicating a fracture within the fiber connector.The remainder of the fiber body was not received.No other problems with the device were noted.The reported event was confirmed.It is likely that procedural handling of the device during set-up or use contributed to the fracture within the fiber connector.A broken fiber within the connector of the device can result in insufficient aiming beam and low laser energy output, up to a complete inability for the fiber to fire, and the fiber connector may be hot to touch.Review and analysis of all available information is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: ACCUTRAC
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): COHERENT INCORPORATED; 5100 patrick henry drive; santa clara CA 95054
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12940931
• Report Number: 3005099803-2021-06390
• Device Sequence Number: 4955476
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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: 10/07/2022
• Device Model Number: M0068404110
• Device Catalogue Number: 840-411
• Device Lot Number: 0000008536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2019
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 66 KG