MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA GASTRO CUFF PILOT SIZE 4

Catalog Number 1E5040

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/12/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The patient's condition was critical but this was not related to the lma.The lma was removed following difficulty of passing through the scope.No injury noted as a result of the scope not passing through the lma nor was any injury noted following removal of the lma.The procedure proceeded without the lma.

Event Description

It was reported that "the endoscopist raised concerns that he found it difficult to pass the scope through the lma".No patient injury reported.

Event Description

It was reported that "the endoscopist raised concerns that he found it difficult to pass the scope through the lma." no patient injury reported.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: LMA GASTRO CUFF PILOT SIZE 4
• Type of Device: LMA GASTRO CUFF PILOT
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8745213
• MDR Text Key: 149647110
• Report Number: 9681900-2019-00022
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

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 Expiration Date: 11/28/2020
• Device Catalogue Number: 1E5040
• Device Lot Number: MMCDXP
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 08/01/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENDOSCOPE; ENDOSCOPE