MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MILLER 2; LARYNGOSCOPE, RIGID

Catalog Number 4150020

Device Problem Optical Obstruction (3002)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reported "the light source on miller 2 blade was completely obstructed by tongue during intubation causing loss of visualization to vocal cords(clinician stated patient had class ii mallampati score).Clinician pulled blade back out of the mouth opening and once again tried intubating with same result.".It was reported the clinician used a different device and successfully intubated the patient.No patient injury or consequence was reported.The patient's condition was reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Although this complaint could not be confirmed, a capa has been opened to address complaints similar in nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The customer reported "the light source on miller 2 blade was completely obstructed by tongue during intubation causing loss of visualization to vocal cords(clinician stated patient had class ii mallampati score).Clinician pulled blade back out of the mouth opening and once again tried intubating with same result.".It was reported the clinician used a different device and successfully intubated the patient.No patient injury or consequence was reported.The patient's condition was reported as "fine".

• Brand Name: RUSCH POLARIS FO BLADE MILLER 2
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8887857
• MDR Text Key: 154135812
• Report Number: 3011137372-2019-00248
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/24/2019

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 Catalogue Number: 4150020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 09/04/2019
• Supplement Dates FDA Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.