MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO SU MEDIUM HANDLE; LARYNGOSCOPE, RIGID

Catalog Number 44402

Device Problem Break (1069)

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

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: a (b)(6) male had desaturated and emergency intubation was necessary.During the intubation the handle broke at the connection of the blade and handle and the blade "snapped off".No harm was done to the patient.The doctor was successfully able to intubate with another device.

Event Description

The complaint is reported as: a 330 lb male had desaturated and emergency intubation was necessary.During the intubation the handle broke at the connection of the blade and handle and the blade "snapped off".No harm was done to the patient.The doctor was successfully able to intubate with another device.

Manufacturer Narrative

(b)(4) the customer returned one 44402 rusch polaris fo su medium handle for investigation.Visual analysis revealed the handle was damaged as parts of the plastic which connects to the blade was missing.Functional inspection was performed in an attempt to replicate the reported failure.A lab inventory handle was attached to a lab inventory emerald 2 blade.Once attached, the handle and blade assembly appeared to be sturdy and very difficult to break.In an attempt to replicate the reported failure, r & d placed a test assembly comprised of a lab inventory handle and emerald 2 blade under the instron tensile strength machine.The test assembly yielded and broke at approximately 220n.The yield starts at the neck and breaks the plastic at the pin, which does not match the failure mode observed in the returned complaint sample.The blade was placed in an incorrect orientation along the handle and subject to an external force.It was observed that the handle had some indentation marks on the back, but not much force was applied on the pin area.This does not match the indentations observed on the returned complaint sample.Per r & d, "the patient was 330lb male.So the head weight is around 27lbs (8.2% of the body weight) which is 120n.The test shows that the laryngoscope combination should handle more than 120n easily and also the failure mode is different in the complaint sample." the ifu for rusch polaris laryngoscope blades states "1.Attach to fiber optic system handle - 2.Click into place - 3.Lift blade and verify illumination." the reported complaint of a broken handle was confirmed.The root cause of this complaint could not be determined.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: RUSCH POLARIS FO SU MEDIUM HANDLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11000021
• MDR Text Key: 222842011
• Report Number: 3011137372-2020-00269
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 44402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EMERALD MILLER 2 BLADE (4452200); EMERALD MILLER 2 BLADE (4452200)
• Patient Weight: 150