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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLED HANDLE: MEDIUM; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLED HANDLE: MEDIUM; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 133300
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
Customer reported that, "the mechanism jammed when the blade and greenlight led handle were connected.Both components cannot be folded or disconnected anymore, not even by force." the issue was detected prior to patient use.No patient involvement reported.
 
Event Description
Customer reported that "the mechanism jammed when the blade and greenlight led handle were connected.Both components cannot be folded or disconnected anymore, not even by force".The issue was detected prior to patient use.No patient involvement reported.
 
Manufacturer Narrative
Qn#(b)(4).The sample was returned and sent to the manufacturer for investigation.The manufacturer reports "when the sample received at site for investigation, the product was found in stuck condition".It was also reported that "further to investigate the defective, we have removed the blade from handle and performed visual inspection to trace the "dent" and "damages" which can cause the stuck issue of blade and handle, but we haven't noticed any dent and damages on handle surface.Even dimensions result verification also carried out for handle and found that all the dimensions of handle were as per product drawing specification.To confirm the compatibility of handle with other blades, we have performed the functional testing with 3 different blades and found that all blades are compatible with handle, handle is working perfectly, there is nothing wrong with the handle." the device history record of lot 200701 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.
 
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Brand Name
RUSCH GREENLED HANDLE: MEDIUM
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10944929
MDR Text Key219513714
Report Number8030121-2020-00160
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 11/11/2020
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 Number133300
Device Lot Number200701
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Initial Date Manufacturer Received 11/11/2020
Initial Date FDA Received12/04/2020
Supplement Dates Manufacturer Received12/15/2020
Supplement Dates FDA Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RUSCH SNAPLIGHT FO BLADE MAC 4; RUSCH SNAPLIGHT FO BLADE MAC 4; RUSCH SNAPLIGHT FO BLADE MAC 4
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