MAUDE Adverse Event Report: GYRUS ACMI, INC. 550 MICRON TFL SINGLE USE FIBER; ELECTRODES, PROBES

Model Number	TFL-FBX550S
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the facility's tfl-pls power supply failed and then the unit began smoking.The event was found during preparation for use in an unspecified therapeutic procedure.There were no reports of patient harm.This event includes two (2) reports.Report with patient identifier (b)(6), model tfl-pls , serial number (b)(6).Report with patient identifier (b)(6) tfl-fbx550s, lot unknown.This report being submitted is for report with patient identifier (b)(6), tfl-fbx550s, lot unknown.
Additional Manufacturer Narrative
The device was not returned to olympus for evaluation and follow up with the user facility is currently being performed.The investigation is ongoing.A supplemental report will be submitted if any additional information is provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Due to no known lot number or returned fiber, the packaging and fiber device history reviews (dhrs) could not be retrieved.If the fiber or additional information permitting the retrieval of the dhrs were to become available at a later date, the investigation shall be updated appropriately.Based on the results of the investigation, a definitive root cause could not be established.The probable cause of the power supply failing and smoking could not be determined.The fiber was not returned to an olympus body, attempts to contact the customer yielded no response.A physical evaluation could not be performed.Moreover, fiber dhr(s) could not be retrieved due to no returned fiber or known lot number.Though this is a soltive fiber, the console instructions for use (ifu) remains applicable - per the soltive laser system instructions for use (ifu): "the soltive laser system is designed for maximum safety and performance.Under normal operating conditions and careful use, a maintenance check of the device is recommended by a qualified technician, every 12 months.¿ olympus will continue to monitor field performance for this device.

• Brand Name: 550 MICRON TFL SINGLE USE FIBER
• Common Device Name: ELECTRODES, PROBES
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17908375
• Report Number: 3003790304-2023-00392
• Device Sequence Number: 8224765
• Product Code: GEX
• UDI-Device Identifier: 00821925044043
• UDI-Public: 00821925044043
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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: Health Professional
• Device Model Number: TFL-FBX550S
• Device Lot Number: UNKNOWN
• 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: 09/14/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1296-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown