MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH LASER TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTO

Model Number	IPN040898
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "patient did not saturate correctly because the tube had a leakage.The tube was retired from the patient and using another tube".No reports of patient injury or harm.Patient condition reported as "fine".
Event or Problem Description
It was reported that "patient did not saturate correctly because the tube had a leakage.The tube was retired from the patient and using another tube".No reports of patient injury or harm.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided photos for evaluation.The photos provided by the customer show a radial tear on the laser guard foil.A device history record (dhr) review was conducted on the reported lot 21011 and no issue that could have contributed to the reported event was identified.The manufacturing site reports: "the laser tube is used for tracheal intubation during laser surgery in the laryngeal area.The laser guard foil prevents the penetration of the laser beam into the tube material (hot tube effect) and minimizes lesions of the mucous membrane.Before application, the entire surface has to be moistened with sterile saline solution, which makes the surface very soft.For intubation a laryngoscope and an intubation aid (intubation stylet) are used to avoid that the tube is bent or torqued in the area of the laser-guard foil.The ifu states explicitly that care has been taken that the tube is not bent, torqued or damaged in the area of the laser-guard foil.During manufacture, the laser tube is subjected to several visual and functional 100% tests, which ensures proper function of the product on leaving the company." based on the photos received, it was confirmed there was a tear on the laser guard foil; however, without the actual device to evaluate the probable cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH LASER TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; 71394 kernen
• MDR Report Key: 11590906
• Report Number: 9610520-2021-00002
• Device Sequence Number: 3396625
• Product Code: BTR
• UDI-Device Identifier: 04026704002658
• UDI-Public: 04026704002658
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K935842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: No Information
• Device Expiration Date: 12/31/2021
• Device Model Number: IPN040898
• Device Catalogue Number: 102004-000050
• Device Lot Number: 21011
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1