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

Model Number	M006R8403920
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results.The returned flexiva id 365 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The piece measured 268.5 cm from the end of the connector to the end of the exposed glass tip.The exposed glass tip measured 3 mm and appeared in good condition.When connected to the laser console, the rfid was able to be recognized without any error messages.Functional analysis revealed that there was no light from the sma connector, indicating a fracture within the fiber connector.No other problems with the device were noted.The reported complaint of rfid connection issue was not confirmed.Although there was no problem detected with the rfid connection, the fracture within the connector likely resulted in difficulty using the fiber.It is likely that procedural handling of the device during set-up 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.Review and analysis of all available information indicated that the root cause 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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a flexiva id 365 laser fiber was used in a lithotripsy procedure in the kidney performed on (b)(6) 2021.The laser unit used was a lumenis 100 watt laser console.During preparation, the laser fiber did not turn on.The procedure was completed with another flexiva id 365 laser fiber.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information: this event has been deemed reportable based on the investigation finding that the laser fiber was broken within the connector.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12594880
• Report Number: 3005099803-2021-05190
• Device Sequence Number: 4290519
• Product Code: GEX
• UDI-Device Identifier: 08714729963776
• UDI-Public: 08714729963776
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 05/27/2024
• Device Model Number: M006R8403920
• Device Catalogue Number: 69269
• Device Lot Number: 0000011135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1