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

Model Number	2130-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the beginning of the ureteroscopy procedure for kidney stones, the fiber got fractured/burned behind the sub miniature a connector.The procedure was completed with another of the same fiber.There were no patient complications.
Event or Problem Description
It was reported that at the beginning of a ureteroscopy procedure for kidney stones, the fiber was fractured and burned behind the sub miniature a connector.The procedure was completed with another fiber and no patient complications.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the reported fiber break event was confirmed by the media provided by the costumer shows a break on the device.The device was not returned for analysis; therefore, technical analysis could not be performed.A review of the device history record confirmed that the fiber met manufacturing specification prior to release.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that at the beginning of the ureteroscopy procedure for kidney stones, the fiber got fractured/burned behind the sub miniature a connector.The procedure was completed with another of the same fiber.There were no patient complications.
Additional Manufacturer Narrative
With all the available information, boston scientific concludes that the reported fiber break event was confirmed by the media provided by the costumer shows a break on the device.The device was not returned for analysis; therefore, technical analysis could not be performed.A review of the device history record confirmed that the fiber met manufacturing specification prior to release.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.

• Brand Name: FLEXIVA PULSE ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan MA 14110 ; MY 14110
• Manufacturer Contact: john stoffregen ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17574500
• Report Number: 2124215-2023-44293
• Device Sequence Number: 21052025
• Product Code: GEX
• UDI-Device Identifier: 08714729978725
• UDI-Public: 08714729978725
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2023

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: 01/02/2026
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030773872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/04/2023; 09/15/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 09/12/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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 Sex: Unknown