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

Model Number 0010-2400

Device Problems Energy Output Problem (1431); Temperature Problem (3022)

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

Event Date 08/25/2022

Event Type  malfunction  

Event Description

The green light moxy laser fiber did not work after using for a short time.The machine read "laser fiber too hot, try different fiber." the fiber did not appear damaged.New fiber opened and used.Old fiber packaging saved and given to service leader.Manufacturer's representative contacted regarding failure.Quality dept.At manufacturer did not wish for us to return the failed device for inspection.

• Brand Name: MOXY LASER FIBER
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15390809
• MDR Text Key: 299573572
• Report Number: 15390809
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2022,08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 29242318
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1