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

Model Number	M0068403920
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a flexiva laser fiber was used during a procedure, performed on (b)(6) 2022.During the procedure, the laser fiber was broken inside the digital flexible ureteroscope while lasering a stone.The broken piece of the laser fiber was successfully removed intact from the patient.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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: 14112448
• Report Number: 3005099803-2022-01921
• Device Sequence Number: 19366661
• Product Code: GEX
• UDI-Device Identifier: 08714729808183
• UDI-Public: 08714729808183
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2024
• Device Model Number: M0068403920
• Device Catalogue Number: 840-392
• Device Lot Number: 0000011178
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female