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

Model Number	2130-02
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a ureteroscopy with stent replacement for kidney stones treatment, the staff noticed a smell like burning rubber.The fiber was disconnected and replaced with a new one.The procedure was completed without patient complications.
Additional Manufacturer Narrative
Upon receive of this device at our quality assurance laboratory, the fiber was visually and functionally tested.Visual examination identified multiple breaks in the fiber body, as well as a break in the sub miniature type a (sma) connector.Based on these observations, the reported allegations were confirmed.It is probable that procedural handling contributed to the damage observed on the fiber.According to the instructions for use (ifu), it is instructed to carefully inspect the fiber for kinks, punctures, fractures, a broken tip (flat or ball), jacket/fiber or other particulates/pieces, or other visual damage.If the fiber appears damaged, do not use the device.Based on all the information available, a conclusion code of cause traced to component failure was identified.
Event or Problem Description
It was reported that during a ureteroscopy with stent replacement for kidney stones treatment, the staff noticed a smell like burning rubber.The fiber was disconnected and replaced with a new one.The procedure was completed without patient complications.
Additional Manufacturer Narrative
Upon receive of this device at our quality assurance laboratory, the fiber was visually and functionally tested.Visual examination identified multiple breaks in the fiber body, as well as a break in the sub miniature type a (sma) connector.Based on these observations, the reported allegations were confirmed.It is probable that procedural handling contributed to the damage observed on the fiber.According to the instructions for use (ifu), it is instructed to carefully inspect the fiber for kinks, punctures, fractures, a broken tip (flat or ball), jacket/fiber or other particulates/pieces, or other visual damage.If the fiber appears damaged, do not use the device.Based on all the information available, a conclusion code of cause traced to component failure was identified.
Event or Problem Description
It was reported that during a ureteroscopy with stent replacement for kidney stones treatment, the staff noticed a smell like burning rubber.The fiber was disconnected and replaced with a new one.The procedure was completed without patient complications.

• 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: 17199677
• Report Number: 2124215-2023-32867
• Device Sequence Number: 12428907
• Product Code: GEX
• UDI-Device Identifier: 08714729978671
• UDI-Public: 08714729978671
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other Health Care Professional
• 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: 01/05/2026
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030799759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 07/10/2023; 09/15/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/28/2023; 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2023
• 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