MAUDE Adverse Event Report: GYRUS ACMI, INC. 550 MICRON TFL SINGLE USE FIBER; POWERED 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.
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 being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, h3, h4, h6 a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over one (1) year since the subject device was manufactured.The device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.Based on the investigation results, laser fiber break/damage, could not be identified.Based on the available details, inspection and testing of the reported device could not be performed due to device not returning.However, a definitive root cause could not be established.Olympus will continue to monitor the field performance for this device.
Additional Manufacturer Narrative
This supplemental report is to inform that upon further review, this is not a reportable malfunction.The initial medwatch reported that the laser fibers wore down and one fiber tip was completely missing during a therapeutic, laser lithotripsy of the bladder stone procedure.Upon further review, it has been determined that the event is not a reportable event.Per the legal manufacturer, 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: POWERED 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: 19591786
• Report Number: 3003790304-2024-00024
• Device Sequence Number: 8525639
• 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,Followup
• Report Date (Section B): 09/26/2024

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; 09/10/2024; 09/17/2024
• Initial Report FDA Received Date: 06/23/2024
• Supplement Report FDA Received Date: 06/25/2024; 09/12/2024; 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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