MAUDE Adverse Event Report: GYRUS ACMI, INC. 550 MICRON TFL SINGLE USE FIBER; LASER SURGICAL INSTRUMENT

Model Number	TFL-FBX550S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to mfr 3003790304 2024 00024.
Event or Problem Description
It was reported that 4 laser fibers wore down and one fiber tip was completely missing during a therapeutic, laser lithotripsy of the bladder stone procedure.The procedure was completed, however multiple laser fibers were used.The procedure was prolonged approximately 10 minutes due to opening additional fibers.The patient's anesthesia or sedation was extended by approximately ten minutes.The condition of the patient was not impacted by the failure and there were no reports of patient harm.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer's contact information and facility registration number.The facility registration number is (b)(4).
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the initial medwatch report (mdr).Further review found there was no reportable malfunction related to the subject device captured in this complaint.The initial mdr was inadvertently submitted as a reportable malfunction.The initial medwatch reported that 4 laser fibers wore down and one fiber tip was completely missing (fiber break).However, it was confirmed by the customer that there was excessive fiber burn back, not a fiber break.Per the legal manufacture, this issue is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: 550 MICRON TFL SINGLE USE FIBER
• Common Device Name: LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19591789
• Report Number: 3003790304-2024-00025
• Device Sequence Number: 8525640
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183647
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

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 Model Number: TFL-FBX550S
• Device Lot Number: KR260935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 06/25/2024; 09/17/2024
• Initial Report FDA Received Date: 06/23/2024
• Supplement Report FDA Received Date: 06/25/2024; 10/02/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown