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

Model Number IPN046946

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 04/28/2022

Event Type  Injury  

Event Description

It was reported that during an ercp procedure with an elderly patient who had previously undergone surgery for cancer, the endoscopist pressed the endoscope through the laryngeal mask so that it punctured the patient's esophagus.Additional information reported stated that the patient was transferred to the icu and is doing well.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during an ercp procedure with an elderly patient who had previously undergone surgery for cancer, the endoscopist pressed the endoscope through the laryngeal mask so that it punctured the patient's esophagus.Additional information reported stated that the patient was transferred to the icu and is doing well.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The manufacturing site reports: "a well placed lma gastro will have its distal tip engage at the upper esophageal sphincter.It is not possible to go further into the esophagus.For ercp procedure, a special endoscope with side viewing camera (duodenoscope) is used.Such endoscope do not have forward viewing camera therefore, the insertion into the patient is always blind insertion.The user will not be able to see the esophagus during insertion.With lma gastro in placed, the duodenoscope will be guided from patient mouth opening into the esophagus with ease." 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.

• Brand Name: LMA GASTRO CUFF PILOT SIZE 4
• Type of Device: LMA GASTRO CUFF PILOT
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14597191
• MDR Text Key: 293311999
• Report Number: 9681900-2022-00016
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/28/2024
• Device Model Number: IPN046946
• Device Catalogue Number: 1E5040
• Device Lot Number: RMA4ZQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/23/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female