MAUDE Adverse Event Report: COHERENT FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	840-396
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.However, media analysis was provided, and it was possible to confirm that the pouch of the device opened.The device history review (dhr) confirmed that the device met all material, assembly and performance specifications.The device did not return for proper analysis; therefore, the root cause cannot be determined.Since the investigation findings do not lead to a clear conclusion about the cause of the reported event, an investigation conclusion code of cause not established was selected as the most probable cause for the complaint.
Event or Problem Description
It was reported that during the procedure, the bottom of the sterile packaging was not sealed.The procedure was completed with another device with no patient complications.

• Brand Name: FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): COHERENT; 32 hampshire rd; salem NH 03079
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork CA T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18360872
• Report Number: 2124215-2023-71438
• Device Sequence Number: 12695469
• Product Code: GEX
• UDI-Device Identifier: 08714729808176
• UDI-Public: 08714729808176
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K110685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2023

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: 11/11/2024
• Device Model Number: 840-396
• Device Catalogue Number: 840-396
• Device Lot Number: M0068403961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2021
• 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