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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH SNAPLIGHT FO BLADE MAC 4; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH SNAPLIGHT FO BLADE MAC 4; LARYNGOSCOPE, RIGID Back to Search Results
Model Number IPN045045
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2020
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Manufacturer Narrative
Qn#(b)(4).Additional information was received from the customer indicating that the product code originally reported was incorrect.The correct product code is a product that is not sold in the us; therefore, the initial report submitted on 12/03/2020 should be retracted.
 
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Brand Name
RUSCH SNAPLIGHT FO BLADE MAC 4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10944961
MDR Text Key219513547
Report Number8030121-2020-00159
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 Health Professional
Device Model NumberIPN045045
Device Catalogue Number670000-000030
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/11/2020
Initial Date FDA Received12/04/2020
Supplement Dates Manufacturer Received11/11/2020
Supplement Dates FDA Received12/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RUSCH GREENLED HANDLE: MEDIUM; RUSCH GREENLED HANDLE: MEDIUM
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