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

Catalog Number 004550003

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that during intubation, the green sheath on the end of the blade came off and was retrieved from the patient's mouth.No patient injury.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the last inch of the distal end of the pipe light that incorporates the green sheath was broken off.Based on the visual exam, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the breakage could not be determined.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.

Event Description

The customer alleges that during intubation, the green sheath on the end of the blade came off and was retrieved from the patient's mouth.No patient injury.The patient's condition is reported as fine.

• 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: 5426932
• MDR Text Key: 37974664
• Report Number: 3011137372-2016-00015
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2016

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: 004550003
• Device Lot Number: 1507432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2016
• 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