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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MILL 3; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREEN RUSCHLITE DISP MTL MILL 3; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004550003
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 05/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved in this complaint has been returned to the manufacturer at the time of this report.However the investigation of said device is still in progress.The investigation into this complaint is still in progress.
 
Event Description
Customer complaint as reported alleges that the miller 3 blade was found to be "damaged" when stocking their crash carts.Customer submitted a photo with the complaint which depicts what appears to be an unpackaged device and broken pieces of materials.There was no report of patient involvement.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the base/and or pipe light is broken.Based on the visual exam, the reported complaint was confirmed.A capa was opened to address the breakage issue.A conclusion code could not be found.
 
Event Description
Customer complaint as reported alleges that the miller 3 blade was found to be "damaged" when stocking their crash carts.Customer submitted a photo with the complaint which depicts what appears to be an unpackaged device and broken pieces of materials.There was no report of patient involvement.
 
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Brand Name
RUSCH GREEN RUSCHLITE DISP MTL MILL 3
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
Manufacturer (Section G)
TRUPHATEK INTERNATIONAL LTD.
14 benny gaon street
p.o. 8051
netanya 42504 43
IS   4250443
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6618133
MDR Text Key76848324
Report Number8030121-2017-00085
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,user f
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number004550003
Device Lot Number1611432
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received06/27/2017
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
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