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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MILL 2; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MILL 2; LARYNGOSCOPE, RIGID Back to Search Results
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 06/27/2016
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 on withdrawing the blade after intubation the green sheath had slid off the light pipe and went down the patient's airway.Intervention - a laryngoscopy was performed to retrieve the item.No patient harm was reported.Patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).Catalog# corrected to 004550003.The complaint description states that the green sheath covering the tip of the fiber optic tube on the laryngoscope blade slid off during intubation.To further evaluate, the sample was visually inspected for flaws.The blade arrived with a total of three breakages in the optic tube that caused the blade to disassemble into six parts.One of the breaks was near the green sheath, as described in the complaint.Rather than just the green sheath sliding off of the fiber optic tube, it was determined that a break on the fiber optic tube, approximately 6mm inside of the green sheath, caused a piece of the fiber optic tube to break off with the green sheath still covering it.The other two breaks were on the plastic base, however, these two breaks were not mentioned in the complaint description, and may or may not have occurred at the customer site.A comparison analysis was then performed to compare the complaint sample to an identical, brand new product to determine if there were any inconsistencies.No dimensional deviations were observed.Based on the investigation performed, the complaint was confirmed.It was determined that the complaint was a result of a break in the fiber optic tube within the green sheath.The blade could have been subjected to external forces beyond the design and essential performance requirements of the device, resulting in breaks in the fiber optic material.The two breaks at the plastic base were not mentioned in the complaint description.Therefore, it is suspected that these two breaks occurred during shipment of the complaint sample from the customer to teleflex (b)(4).The root cause of failure was likely damage that occurred during transportation from the manufacturer to the consumer.A conclusion code could not be found.
 
Event Description
The customer alleges that on withdrawing the blade after intubation the green sheath had slid off the light pipe and went down the patient's airway.Intervention - a laryngoscopy was performed to retrieve the item.No patient harm was reported.Patient's condition is reported as fine.
 
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Brand Name
RUSCH GREEN RUSCHLITE DISP MTL MILL 2
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 Key5791839
MDR Text Key49453938
Report Number3011137372-2016-00218
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number004550003
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received08/16/2016
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 Number1
Patient Outcome(s) Required Intervention;
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