LMA PROSEAL, REU, SIZE 3 (150030)

Report

Report Number: 9681900-2017-00024
Event Type: Malfunction
Date Received: May 16, 2017
Date of Event: April 3, 2017
Report Date: April 27, 2017
Manufacturer: TELEFLEX MEDICAL
Product Code: CAE
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

QN#(B)(4). THE INVESTIGATION INTO THIS COMPLAINT IS STILL IN PROGRESS AT THE TIME OF THIS REPORT.

Additional Manufacturer Narrative · 1

(B)(4). A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED.

Description of Event or Problem · 1

CUSTOMER COMPLAINT ALLEGES " AN AIRWAY LEAK WAS DETECTED WHILST IN THE OPERATING THEATRE, CHECKS REVEALED THE SHOULDER OF A PROSEAL LMA HAD PARTIALLY SHEARED OFF CREATING THE LEAK." IT WAS REPORTED THAT THE DEVICE WAS REPLACED WITH A DIFFERENT AIRWAY. IT IS UNCLEAR WHETHER THE ALLEGED EVENT OCCURRED DURING USE OR PRIOR TO USE DURING FUNCTIONAL TESTING. IT WAS REPORTED THERE WAS NO PATIENT INJURY. PATIENT CONDITION REPORTED AS "FINE".

Description of Event or Problem · 1

CUSTOMER COMPLAINT ALLEGES " AN AIRWAY LEAK WAS DETECTED WHILST IN THE OPERATING THEATRE, CHECKS REVEALED THE SHOULDER OF A PROSEAL LMA HAD PARTIALLY SHEARED OFF CREATING THE LEAK." IT WAS REPORTED THAT THE DEVICE WAS REPLACED WITH A DIFFERENT AIRWAY. IT IS UNCLEAR WHETHER THE ALLEGED EVENT OCCURRED DURING USE OR PRIOR TO USE DURING FUNCTIONAL TESTING. IT WAS REPORTED THERE WAS NO PATIENT INJURY. PATIENT CONDITION REPORTED AS "FINE".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
350590	LMA PROSEAL, REU, SIZE 3 (150030)	AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY	CAE	TELEFLEX MEDICAL		8URACFNU

Patients

Seq	Age	Sex	Outcome	Treatment
1