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

Model Number	M0068403910
Medical Device Problem Codes	Degraded (1153); Overheating of Device (1437); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a flexiva 200 laser fiber was used in a ureteroscopy procedure in the ureter performed on (b)(6) 2021.The laser unit used was a lumenis p120 laser console with laser settings of 1.80 hertz, 0.3 joules and 10hertz, 0.8 joules during the procedure, when the staff member removed the laser fiber she burned her finger as it was very hot.The burnt finger was treated by cold water.The procedure was completed with another flexiva 200 laser fiber laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a1005 captures the reportable event of fiber connector overheats.Block h10: investigation results: the returned flexiva laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The piece measured 35.5cm.The remainder of the fiber, including the distal tip was not returned.The distal end of the fiber body appeared to have been manually clipped.Visual inspection of the fiber observed the sma boot was damaged/detached.A functional evaluation revealed that there was no light from the sma connector, indicating a fracture within the connector.The condition of the sma boot was indicative of the connector overheating.No other problems with the device were noted.The reported event of the flexiva laser fiber overheating was confirmed.It is likely that procedural handling of the device during set-up or use 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.Additionally, the ifu states, in the event of reduced or no laser energy output during application the fiber connector may be hot to touch.Review and analysis of all available information indicated that the most probable 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 laser fiber was used in a ureteroscopy procedure in the ureter performed on (b)(6) 2021.The laser unit used was a lumenis p120 laser console with laser settings of 1.80 hertz, 0.3 joules and 10hertz, 0.8 joules.During the procedure, the fiber connector was hot and a staff member received a burn to her finger from the hot laser fiber connector when removing the fiber from the laser console.The laser fiber rubber boot was detached.The procedure was completed with another flexiva laser fiber.There were no patient complications reported as a result of this event and the staff members burnt fiber was treated with cold water.

• Brand Name: FLEXIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): COHERENT INCORPORATED; 5100 patrick henry drive; santa clara CA 95054
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13025669
• Report Number: 3005099803-2021-07876
• Device Sequence Number: 19264192
• Product Code: GEX
• UDI-Device Identifier: 08714729808145
• UDI-Public: 08714729808145
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 04/23/2024
• Device Model Number: M0068403910
• Device Catalogue Number: 840-391
• Device Lot Number: 0000010982
• 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: 11/25/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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