• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL EXTRACTION BAG FOR MIS CATHETER, PERCUTANEOUS Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXTRACTION BAG FOR MIS
Type of DeviceCATHETER, 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 Key7677116
MDR Text Key113639764
Report Number3006425876-2018-00408
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 06/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number332800-000010
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2018
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

-
-