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

Model Number	M006L8406960
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure while the surgeon was using the laser, the flexiva pulse id tractip ("laser fiber") connected to the laser unit broke in half.Wet towel placed on top of the patient and a the patient drape had small burn holes.The drop was on top of a stirrup cover, so it did not touch the patient.Neither the patient or any member of the operating room team was harmed.Fda safety report id # (b)(4).

• Brand Name: FLEXIVA LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 14574775
• Report Number: MW5110024
• Device Sequence Number: 11672330
• Product Code: GEX
• UDI-Device Identifier: 08714729978718
• UDI-Public: 08714729978718
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/27/2022

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: 01/26/2025
• Device Model Number: M006L8406960
• Device Catalogue Number: M006L8406960
• Device Lot Number: 28755471
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male