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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA CLASSIC EXCEL SIZE 3; AIRWAY, OROPHARYNGEAL, ANESTHE
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TELEFLEX MEDICAL LMA CLASSIC EXCEL SIZE 3; AIRWAY, OROPHARYNGEAL, ANESTHE Back to Search Results
Catalog Number 902030
Device Problem Material Puncture/Hole (1504)
Patient Problem No Patient Involvement (2645)
Event Date 08/10/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer complaint reported as: there is a hole somewhere in the lma that is not allowing it to function properly.It was reported the holes were detected when the doctor was going to put it in use.The device was not used on the patient.
 
Manufacturer Narrative
Conclusion: the device history record for the valve was reviewed and showed that this device met all manufacturing specifications for final product released for distribution.No issues were identified that would have impacted this event.High gradients increase over time are typically related to patient factors such as, but not limited to, thrombus formation, calcification, patient pressures, and/or anatomical left ventricular outflow tract (lvot) obstruction, etc.However, as the device remains implanted, and the images were not provided for review, a conclusive root cause could not be determined.This event does not indicate device misuse or malfunction.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Customer complaint reported as: there is a hole somewhere in the lma that is not allowing it to function properly.It was reported the holes were detected when the doctor was going to put it in use.The device was not used on the patient.
 
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Brand Name
LMA CLASSIC EXCEL SIZE 3
Type of Device
AIRWAY, OROPHARYNGEAL, ANESTHE
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key10448405
MDR Text Key204204678
Report Number9681900-2020-00012
Device Sequence Number1
Product Code CAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Type of Report Initial,Followup
Report Date 08/10/2020
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 Catalogue Number902030
Device Lot Number73UAAPHN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2020
Initial Date Manufacturer Received 08/10/2020
Initial Date FDA Received08/25/2020
Supplement Dates Manufacturer Received09/25/2020
Supplement Dates FDA Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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