MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MILL 3; LARYNGOSCOPE, RIGID

Catalog Number 004550003

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 02/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample is currently in the custody of risk management at the user facility and until further notice it is not available for return to teleflex for investigation purposes.

Event Description

The customer alleges that a physician had inserted the green ruschlite disposable mac 3 laryngoscope blade into the patient throat of a surgical patient.The physician saw that the sheathed end of the pipe light detached from the blade and fell out of the line of sight and down the patient's throat.The surgical procedure was delayed.Intervention - a bronchoscopy was performed to find and retrieve the sheathed green tip of the pipe light in the patient's airway.The user facility reports that the patient was not harmed in any way as a result of the incident.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that a physician had inserted the green ruschlite disposable mac 3 laryngoscope blade into the patient throat of a surgical patient.The physician saw that the sheathed end of the pipe light detached from the blade and fell out of the line of sight and down the patient's throat.The surgical procedure was delayed.Intervention - a bronchoscopy was performed to find and retrieve the sheathed green tip of the pipe light in the patient's airway.The user facility reports that the patient was not harmed in any way as a result of the incident.

• Brand Name: RUSCH GREEN RUSCHLITE DISP MTL MILL 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5453648
• MDR Text Key: 38768567
• Report Number: 3011137372-2016-00035
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 02/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004550003
• Device Lot Number: 1511432
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention