MAUDE Adverse Event Report: COHERENT FLEXIVA; POWERED LASER SURGICAL INSTRUMENT

Model Number	840-391
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of these flexiva fiber at our quality assurance laboratory, the returned device underwent a thorough analysis.It was found tip degraded which is expected for consumable devices and the fiber connector was fractured.The connector may have a developed a microfracture that with use or handling can become larger resulting in an insufficient aiming beam and low laser energy output, up to a complete inability for the fiber to fire.Based on the information available and analysis results, the fracture identified could have caused or contributed to the reported clinical observation of fiber stop working.
Event or Problem Description
It was reported that after the beginning of the lithotripsy, the fiber stopped working for no apparent reason.The procedure was completed using another unit.No patient complications were reported.Upon device evaluation, it was found that the fiber connector was fractured.

• Brand Name: FLEXIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): COHERENT; 32 hampshire rd; salem NH 03079
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 16228776
• Report Number: 2124215-2023-02037
• Device Sequence Number: 5249694
• Product Code: GEX
• UDI-Device Identifier: 08714729808145
• UDI-Public: 08714729808145
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/23/2023

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: 08/12/2024
• Device Model Number: 840-391
• Device Catalogue Number: 840-391
• Device Lot Number: 0000011478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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: Female