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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA GASTRO CUFF PILOT SIZE 4
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TELEFLEX MEDICAL LMA GASTRO CUFF PILOT SIZE 4 Back to Search Results
Catalog Number 1E5040
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/22/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the balloon of the device was stuck in the larynx of the patient because the doctor was unable to deflate the balloon.The doctor has stated that it was user error as he acknowledged he did not use the correct syringe and did not follow the ifu guidelines.It was also reported that "during the incident he pulled on the device to remove the tube with the balloon inflated but there was no pain for any patient." since the event, an in-service has been performed with the doctor.No patient injury/harm reported.The condition of the patient was reported as "fine".
 
Event Description
It was reported that the balloon of the device was stuck in the larynx of the patient because the doctor was unable to deflate the balloon.The doctor has stated that it was user error as he acknowledged he did not use the correct syringe and did not follow the ifu guidelines.It was also reported that "during the incident he pulled on the device to remove the tube with the balloon inflated but there was no pain for any patient." since the event, an in-service has been performed with the doctor.No patient injury/harm reported.The condition of the patient was reported as "fine".
 
Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was available for analysis.The investigation report from the manufacturing site states "the french product manager performed a training to the doctor who reported the incidents.He figured out that the doctor was not using the correct syringe and thus was not using the device prior to use, which explained why they could not deflate the balloon.The root cause of the incidents was classified as user error.".
 
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Brand Name
LMA GASTRO CUFF PILOT SIZE 4
Type of Device
LMA GASTRO CUFF PILOT
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key8841660
MDR Text Key152657259
Report Number9681900-2019-00031
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 company representative,foreig
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/28/2021
Device Catalogue Number1E5040
Device Lot NumberNMCPRQ
Was Device Available for Evaluation? No
Date Manufacturer Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED; NOT REPORTED
Patient Outcome(s) Life Threatening; Other; Required Intervention;
Patient Age69 YR
Patient Weight99
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