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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004551004
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 04/22/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported prior to patient use, the blade cannot be tightly attached to the laryngoscope handle because a metal piece is bent at the blade's clamping device, preventing contact with the light source.
 
Manufacturer Narrative
(b)(6).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and small broken pieces were observed in the packaging.It was also stated that the spot welding joint was intact.The manufacturer reports that this product family is inspected 100% prior to shipment so it is confirmed that the device left the manufacturing site fully functional.The device history record of the lot number of the sample received was reviewed and no issues that could have contributed to the reported failure were noted.The device was manufactured according to release specification.Based on the investigation performed, the complaint is confirmed.It seems that for some reason it sustained unexplained physical damage.The product cannot withstand the unexplained external impact.Because of the increasing trend in greenlite breakage complaints, a capa has been opened to address this issue.
 
Event Description
Customer reported prior to patient use, the blade cannot be tightly attached to the laryngoscope handle because a metal piece is bent at the blade's clamping device, preventing contact with the light source.
 
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Brand Name
RUSCH GREENLITE DISP MTL MAC 4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10040207
MDR Text Key198208576
Report Number8030121-2020-00083
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,foreig
Type of Report Initial,Followup
Report Date 04/22/2020
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 No Information
Device Catalogue Number004551004
Device Lot Number1907341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2020
Initial Date Manufacturer Received 04/22/2020
Initial Date FDA Received05/08/2020
Supplement Dates Manufacturer Received06/09/2020
Supplement Dates FDA Received06/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.
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