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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISPOSABLE METAL BLADE MILLER1; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE DISPOSABLE METAL BLADE MILLER1; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004550001
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/03/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: a resident/fellow performed a routine intubation on a pediatric patient successfully.The resident/fellow commented that the blade looked odd and a piece was missing.The patient is doing fine and no injuries were reported.
 
Manufacturer Narrative
(b)(4).The sample was not returned; however, the customer provided a photo for evaluation.A visual exam was performed on the photo and it was observed that the pipe of the light guide is broken.The manufacturer reports that the device is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.It seems as though the device sustained unexplained physical damage.
 
Event Description
The complaint is reported as: a resident/fellow performed a routine intubation on a pediatric patient successfully.The resident/fellow commented that the blade looked odd and a piece was missing.The patient is doing fine and no injuries were reported.
 
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Brand Name
RUSCH GREENLITE DISPOSABLE METAL BLADE MILLER1
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8587778
MDR Text Key144316373
Report Number8030121-2019-00040
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number004550001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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