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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NULL PORTEX LARYNGOSCOPE BLADES; LARYNGOSCOPE, RIGID
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NULL PORTEX LARYNGOSCOPE BLADES; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 2955.150.20
Device Problem Optical Problem (3001)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/12/2021
Event Type  malfunction  
Event Description
It was reported that the device had blind spots during an intubation within the light channel after preparation / sterilization of the spatula.No patient injury was reported.
 
Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).The investigation was conducted by the supplier.The investigation concluded that spotting and light output degradation is often a care and maintenance issue, especially if other companies' items are also having the same issue.A failure of the blade light guide would be unlikely.The results reported indicated the event was confirmed.The root cause was determined to be improper care and maintenance.D3, d4, g2, g5 all unknown.
 
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Brand Name
PORTEX LARYNGOSCOPE BLADES
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section G)
NULL
MDR Report Key16746766
MDR Text Key313358476
Report Number3012307300-2023-04170
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/14/2023
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 Catalogue Number2955.150.20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/14/2023
Initial Date FDA Received04/14/2023
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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