MAUDE Adverse Event Report: IPG MEDICAL CORPORATION THUVERA 200UM SINGLE USE FLAT TIP FIBER; SURGICAL LASER FIBER

Catalog Number	MD2300F-001635
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information regarding the event and return of the device have been requested from the reporter.No additional information has been provided.Without the lot number or device, no investigation can be conducted.
Event or Problem Description
It was reported that a fiber tip broke off in patient.The physician tried to basket out the broken piece of fiber but was not successful.Next course of action is unknown.There were no patient complications.

• Brand Name: THUVERA 200UM SINGLE USE FLAT TIP FIBER
• Common Device Name: SURGICAL LASER FIBER
• Manufacturer (Section D): IPG MEDICAL CORPORATION; 225 cedar hill street; marlborough MA 01752
• Manufacturer (Section G): IPG MEDICAL CORPORATION; 225 cedar hill street; marlborough MA 01752
• Manufacturer Contact: kevin o'connell ; 225 cedar hill street; marlborough, MA 01752 ; 7746335903
• MDR Report Key: 23613649
• Report Number: 3020221089-2025-00001
• Device Sequence Number: 13003901
• Product Code: GEX
• UDI-Device Identifier: 00810071230035
• UDI-Public: 00810071230035
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K232568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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 Catalogue Number: MD2300F-001635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown