MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM; INSTRUMENT, LIGATURE PASSING A

Catalog Number EFX002

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that while using this device for a gastric sleeve procedure, the doctor was not able to grab the suture with the suture grasper.The sales representative was in attendance and asked the doctor to attempt to grab/capture the suture three times before we stopped the attempt to capture the suture.It appeared that maybe a portion of the metal tip (hook) of the grasper had broken off, not allowing the grasper to latch onto the suture.Note that the suture was properly positioned on the device at the time of the attempt.Further information indicates that the broken device part fell inside the patient and it was retrieved without any additional intervention.The were no complications at all.

• Brand Name: WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
• Type of Device: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 9660349
• MDR Text Key: 191033215
• Report Number: 3011137372-2020-00054
• Device Sequence Number: 1
• Product Code: HCF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2022
• Device Catalogue Number: EFX002
• Device Lot Number: 3334260000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1