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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID
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RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID Back to Search Results
Model Number IPN048386
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/10/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
 
Event or Problem Description
Customer reported 4 broken blades from the same lot.No patient involvement reported.
 
Event or Problem Description
Customer reported 4 broken blades from the same lot.No patient involement reported.
 
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
RUSCH GREENLITE DISP MTL MAC 4
Common Device Name
LARYNGOSCOPE, RIGID
MDR Report Key12579822
Report Number8030121-2021-00030
Device Sequence Number17065612
Product Code CCW
UDI-Device Identifier14026734626074
UDI-Public14026734626074
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/10/2021
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
Operator of Device No Information
Device Expiration Date09/01/2025
Device Model NumberIPN048386
Device Catalogue Number004551004
Device Lot Number2010341
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 09/10/2021
Supplement Date Received by Manufacturer10/27/2021
Initial Report FDA Received Date10/05/2021
Supplement Report FDA Received Date10/27/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured10/17/2020
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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