MAUDE Adverse Event Report: TELEFLEX MEDICAL EXTRACTION BAG FOR MIS; CATHETER, PERCUTANEOUS

Catalog Number 332800-000010

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Pain (1994)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.The device is not available for investigation.The device history review cannot be conducted since the device lot number was not provided.The wire, including both eyes, is 100% inspected several times during production and in case of the reported defect, detached protective tube of guide wire or detached part of wire, such defect should be immediately detected and scrapped.There were reported 31 complaints connected with the product in the reviewed time frame including this complaint.This is the 6th complaint from 6 complaints reported for similar issue "broken wire/wire issue".Other remarks: there were reportedly totally 45 complaints connected with memobag products in the reviewed time frame including this complaint.This is the 10th complaint from 10 complaints reported for a similar issue.The root cause of these complaints was determined as improper method of use or unknown root cause because of missing information from the user and not returned sample for examination.Ifu prescribes, to remove the memobag, use graspers to grasp the closure loop located at the end of the closure wire.Retract the closure loop through the trocar to securely close the memobag, sealing the tissue inside.Continue to retract the closure loop until the memobag is at the base of the trocar.With the memobag at the base of the trocar, withdraw the trocar sheath, memobag and graspers until the closed mouth of the memobag is at the trocar incision site.Continue to remove the memobag through the trocar incision site by hand under direct vision.The root cause of the reported defect cannot be clearly determined based on the provided information regarding the reported defect and unavailable defective device and therefore no corrective or preventive actions are necessary.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a (b)(6) female patient had pelvic pain.She had an ovarian cyst.An intervention was performed (b)(6) 2017.The patient went home 1 day after the surgery then came back for a follow up 11 june 2018; she had pain.On the x ray performed because she felt this pain, it was observed that there is a small piece of thread 4-5 cm in her pelvis.The foreign material is the end of the thread of the bag used during the laparoscopy and this is a small part that was cut on the trocar when the bag was removed.

• Brand Name: EXTRACTION BAG FOR MIS
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 7677116
• MDR Text Key: 113639764
• Report Number: 3006425876-2018-00408
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 332800-000010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• 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
• Patient Age: 20 YR