MAUDE Adverse Event Report: GYRUS ACMI L.P. 150 MICRON TFL BALL TIP SINGLE USE FIBER; POWER LASER SURGICAL INSTRUMENT

Model Number	TFL-FBX150BS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received to date.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time, however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported that a failure occurred with the 150 micron tfl ball tip single use fiber.The fiber was connected in the standard fashion to the soltive at a setting of 0.2j and100hz.A short pulse duration was selected and immediately upon hitting the pedal for the first time, there was a noise from the connector.The fiber optic part of the fiber was detached from the connector and the very end of the connector ignited with a small flame.The customer instantly recognized the abnormal sound and put a wet towel over the connector that extinguished the flame.Afterwards, the connector was removed from the fiber.The event occurred during preparation for use and a similar device was used to complete the operation.There was no patient harm or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and the device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The fiber was returned in sealed tyvek package.The failure mode of fiber break was confirmed at the proximal end of the fiber.There are slight burn marks that confirm the sparking/fire coming from the connector.There is indication of light use from slight burn back of the distal end of the fiber.There are no other physical deformities or issues with the fiber.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the fiber break was due to combination of the strain relief not properly reducing the strain on the connector and possible mis-handling by the user.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.
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).

• Brand Name: 150 MICRON TFL BALL TIP SINGLE USE FIBER
• Common Device Name: POWER LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14431532
• Report Number: 8010047-2022-08420
• Device Sequence Number: 20465698
• Product Code: GEX
• UDI-Device Identifier: 00821925043916
• UDI-Public: (01)00821925043916(17)250128(10)KR206014
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2024

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-FBX150BS
• Device Lot Number: KR206014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 03/03/2023; 06/18/2024
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 03/28/2023; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown