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

Model Number	M0068404110
Medical Device Problem Codes	Break (1069); Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: the returned accutrac 200 laser fiber was analyzed, and a visual evaluation noted that it was returned in two pieces.The first piece measured approximately 267.6 mm from the break to the distal tip and the second piece measured 44.6 mm from the top of the connector to the break.The overall length of the device was approximately 312.2 mm, therefore it is likely that the entirety of the fiber was returned.The fiber tip measured approximately 3.5 mm and the tip appeared to be fractured.Visual examination revealed that the light cannot travel well to the fiber face within the sma connector to illuminate it fully, indicating that the fiber is broken within the connector.It is likely that due to the fracture within the connector that the fiber would fail to fire.No other issues with the device were noted.The condition of the returned device revealed that the device was broken, likely as a result of how the device was handled during setup or as it interacted with the scope.In addition, it was also noted that the fiber tip was fractured.The fiber tip may break under adverse conditions during procedure.The tip can interact with the scope as it passes through, which in tortuous anatomy can cause stresses that can result in a fiber tip damage.The reported complaint was confirmed.The returned fiber was analyzed as fractured within the sma connector.It is likely that the handling of the device during setup caused damage to the fiber within sma connector.Damage 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.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.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 directions for use (dfu) / product label.
Event or Problem Description
This report pertains to the third of three devices that were used in the same procedure.Refer to manufacturer report number mfr.Report # 3005099803-2020-04490 for the first accutrac 200 laser fiber, mfr.Report # 3005099803-2020-04491 for the second accutrac 200 laser fiber and mfr.Report # 3005099803-2020-04492 for the third accutrac 200 laser fiber.It was reported to boston scientific corporation on (b)(6) 2020 that an accutrac 200 laser fiber was used in a ureteroscopy procedure performed on (b)(6)2020.According to the complainant, during the procedure, when the physician stepped on the foot pedal, there was no energy traveling through the fiber.A second and third of the same device were opened and the same issue occurred.The procedure was completed with a fourth accutrac 200 laser fiber.There were no patient complications reported as a result of this event.Boston scientific corporationhas been unable to obtain additional information regarding the event to date, despite good faith efforts.This event has been deemed a reportable event based on the investigation finding of the laser fiber was broken within the connector, fiber body broke and fiber tip detached.Please see for full investigation details.

• Brand Name: ACCUTRAC
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10673007
• Report Number: 3005099803-2020-04492
• Device Sequence Number: 2948479
• Product Code: GEX
• UDI-Device Identifier: 08714729802716
• UDI-Public: 08714729802716
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/13/2020

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: 10/04/2021
• Device Model Number: M0068404110
• Device Catalogue Number: 840-411
• Device Lot Number: 0000006690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1