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

Model Number M006L8406960

Device Problems Break (1069); Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2022

Event Type  malfunction  

Event 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
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 14574775
• MDR Text Key: 293280841
• Report Number: MW5110024
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 08714729978718
• UDI-Public: 08714729978718
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male