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

Model Number	2130-02
Medical Device Problem Codes	Melted (1385); 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	08/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this fiber melted close to the sub miniature a (sma) connector.It was noted that the fiber being melted was identified before using it with the patient.The fiber was changed, and the procedure was completed with a new fiber with no patient complications.
Event or Problem Description
It was reported that this fiber melted close to the sub miniature a (sma) connector.It was noted that the fiber being melted was identified before using it with the patient.The fiber was changed, and the procedure was completed with a new fiber with no patient complications.
Additional Manufacturer Narrative
Correction: g1 manufacturing site information upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual analysis identified a fiber body as the fiber was received in two pieces.The fiber connector was not received.In addition, burn marks were identified on the sma boot and a kink was observed above the sma boot.The fiber tip measured 3 mm and had normal degradation.It is likely that procedural conditions, such as physician technique, size and composition of the material being ablated, may have contributed to the sma boot to melt leading to the fiber break.According to the device instructions for use, the following is cautioned: 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.If it is an unused device, return it to boston scientific for replacement.Based on analysis results and information available, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that this fiber melted close to the sub miniature a (sma) connector.It was noted that the fiber being melted was identified before using it with the patient.The fiber was changed, and the procedure was completed with a new fiber with no patient complications.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this device was thoroughly analyzed.Visual analysis confirmed a fiber body break as the fiber was received in two pieces.The fiber connector was not received.In addition, burn marks were noted on the sub-miniature a boot and a kink was observed above the sma boot.The fiber tip measured 3 mm and had normal degradation.It is likely that procedural conditions, such as procedural technique, size and composition of the material being ablated, may have caused the sma boot to melt leading to the fiber break.According to the device instructions for use, the following is cautioned: 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.If it is an unused device, return it to boston scientific for replacement.Based on analysis results and information available, a conclusion code of cause traced to component failure was assigned to this investigation.Correction: g1 manufacturing site information.
Event or Problem Description
It was reported that, during a neprhostolithotomy procedure, smoke was emanating from where the fiber connected to the console.As a result, the procedure was paused, the machine was turned off, and the fiber was immediately taken out of the machine.It was noted that the smoke was due to the fiber being overheated.The procedure was completed with a new fiber with no 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17608528
• Report Number: 2124215-2023-45611
• Device Sequence Number: 20688124
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2023

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: 12/01/2025
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0030637168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2023
• Supplement Date Received by Manufacturer: 09/15/2023; 09/28/2023; 10/25/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/18/2023; 10/19/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2022
• 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