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 Fracture (1260); Sparking (2595)

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

Event Date 03/04/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received at service business center (sbc) olympus and is being shipped to the original equipment manufacturer (oem) for investigation.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported during a therapeutic cysto-urethroscopy procedure, sparks observed then laser fiber was ruptured.Per the report, after replacing the device (with similar device) sparks continued to appear until end of the procedure.The intended procedure was completed using a similar device.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation, and corrections to e1, e2, e3, and g2.The information included in e1, e2, e3, and g2 was inadvertently omitted from the initial medwatch report.Please see updates to e1, e2, e3, g2, h3, h4, h6 and h10.The device was returned to olympus for inspection, and the customer's complaint was confirmed.The device connector was completely separated from the rest of the fiber body.The strain relief section was missing and there was major charring/ melting where the strain relief should be.Moving the connector produces a soft rattling sound suggesting there may internal damage or parts loose within the connector.The length of the fiber body does not have any physical or visual defects along the fiber shaft.The two fiber ends are not clearly distinguishable between the distal tip and the side that broke away at the connector.One side is severely burnt and has signs of use.The other appears to have broken off, it is unclear if this broken side is from the tip breaking off or from the tip burning back without charring the blue protective coating.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 device ruptured due to the fiber being mishandled.The device could not be tested for the fiber tip flaring and thus a final root cause for the flaring could not be determined.The following is included in the instructions for use: "inspect the quality of the optical fiber based on the output pattern of the laser spot.A well-defined circular pattern indicates an ideal cleave.See figure 1a" - soltive single-use laser fiber ifu pg 11 "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)." - soltive single-use laser fiber ifu pg 10 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.; 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: 16893042
• MDR Text Key: 314813440
• Report Number: 3003790304-2023-00185
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: K183647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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
• Device Operator: Health Professional
• Device Model Number: TFL-FBX200BS
• Device Lot Number: KR262829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/18/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• 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