MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MAC 5; LARYNGOSCOPE, RIGID

Model Number IPN915504

Device Problem Intermittent Loss of Power (4016)

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

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "blade used with about half of our laryngoscope handles (heine), the blades light up during a function check when you just fold the blade up, but when under load, such as when laryngoscopy a patient, the light goes out." additional information received stated that "the problem that has risen is that during intubation, the laryngoscope blade has gone out.During control, the blade lights up, but during intubation, where there is another pressure on the blade, it goes out." no patient injury, harm, or consequence reported.Patient condition reported as "doing well.".

Event Description

It was reported that: "blade used with about half of our laryngoscope handles (heine), the blades light up during a function check when you just fold the blade up, but when under load, such as when laryngoscopy a patient, the light goes out." additional information received stated that "the problem that has risen is that during intubation, the laryngoscope blade has gone out.During control, the blade lights up, but during intubation, where there is another pressure on the blade, it goes out." no patient injury, harm, or consequence reported.Patient condition reported as "doing well.".

Manufacturer Narrative

Qn#(b)(4).Associated mdr 3011137372-2022-00201.The customer returned one 4150130 rusch polaris fo blade mac 3 for investigation.Visual examination did not reveal any obvious defects or anomalies.The device appeared typical.Functional inspection was performed by attaching the blade to a known good rusch dispoled lab inventory handle.To switch on, the blade was pulled up and the blade was able to properly illuminate.Then a load was applied to the blade and handle using a weight scale as the customer complaint stated that the light did not illuminate once force was applied to it.The blade was applied a continuous force of up to approximately 6lbs and the light did not turn off at any point.There were no visual signs of any light deficiency within the blade.This testing was performed with an additional lab inventory handle to confirm the results.Testing with the second lab inventory handle also revealed proper light function of the returned blade.The manufacturing dhr file was reviewed based on the lot reported.No recorded results of manufacturing issues or anomalies were reported.The complaint cannot be confirmed.Functional testing confirmed that the blade was able to properly illuminate with multiple lab inventory handles attached.The returned blade was put under an applied load and the light did not turn off at any point.No issues were identified with the light function of the blade.A device history record review was performed with no relevant findings identified.Therefore, the complaint cannot be confirmed as there was no fault found with the device.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: RUSCH POLARIS FO BLADE MAC 5
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15651998
• MDR Text Key: 306516699
• Report Number: 3011137372-2022-00200
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711847
• UDI-Public: 14026704711847
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

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 Model Number: IPN915504
• Device Catalogue Number: 4150130
• Device Lot Number: 2008004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 11/15/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: HANDLE; HANDLE