MAUDE Adverse Event Report: GYRUS ACMI, INC. 200 MICRON TFL BALL TIP SINGLE USE FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number TFL-FBX200BS

Device Problems Break (1069); Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported, the single use fiber had broken fibers.There were no reports of patient harm.

Event Description

It was reported that the subject device fibers broke during a therapeutic cystoscopic laser lithotripsy procedure.The procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.The fiber was broken directly at the end of the strain relief point, with strain relief side of the break having clear signs of burning with discoloration and melted plastic.Mechanical testing (rfid) found the device had worked as expected.Based on the results of the investigation, the event was primarily linked to procedural factors (device handling); however, a definitive root cause could not be determined.The event can be detected/prevented by following the instructions for use: soltive¿ superpulsed laser fiber single-use it was found that the device handling section states "do not bend or coil the soltive laser fibers beyond the recommended minimum bend radius (table 2); doing so may result in light leakage or fiber breakage that could cause personal injury if the laser is fired (refer to the laser system manual)." and device preparation section states "if any damage is observed such as breaks, kinks or damaged components, do not use the fiber, retain the device for manufacturer notification and use a replacement fiber".Olympus will continue to monitor field performance for this device.

• Brand Name: 200 MICRON TFL BALL TIP SINGLE USE FIBER
• Type of Device: 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: 19126962
• MDR Text Key: 340465886
• Report Number: 3011050570-2024-00133
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/06/2024

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
• Device Operator: Health Professional
• Device Model Number: TFL-FBX200BS
• Device Lot Number: KR373721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 05/28/2024
• Supplement Dates FDA Received: 06/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG