MAUDE Adverse Event Report: LASER PERIPHERALS, LLC HTB-365-PL; POWERED LASER SURGICAL INSTRUMENT

Model Number	HTB-365-PL
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
3 fibers broke and wore out faster than they are supposed to.Continued to open fibers until one worked correctly.

• Brand Name: HTB-365-PL
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LASER PERIPHERALS, LLC; 13355 10th avenue north, suite 110; plymouth MN 55441
• MDR Report Key: 16223292
• Report Number: 16223292
• Device Sequence Number: 12080507
• Product Code: GEX
• UDI-Device Identifier: 00816469020448
• UDI-Public: (01)00816469020448(17)240606(10)DF19007
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2023
• Report Date (Section F): 01/18/2023

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: Other
• Device Model Number: HTB-365-PL
• Device Catalogue Number: HTB-365-PL
• Device Lot Number: DF19007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/23/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 01/18/2023