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

MAUDE Adverse Event Report: TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL UNCOVERED STENT; PYLORIC & DUODENAL STENT

  • 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
 

TAEWOONG MEDICAL CO.,LTD. NITI-S PYLORIC & DUODENAL UNCOVERED STENT; PYLORIC & DUODENAL STENT Back to Search Results
Model Number DXDT2212
Device Problems Break (1069); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that dxdt2212, which had been placed on pylorus for pyloric stenosis around april, was found being fractured and the fractured part was in stomach.It is hard to confirm the manufacturing history of the product because the serial number was not informed to us.Fracture can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.Duodenum structure where stent was implanted is curvy.Stent can be frequently pressured due to patient's lesion status, and fracture be possible.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is hard to identify the root cause since it is difficult to reconstruct the situation at the time of procedure, and the suspected device was not returned.However, based on the description "dxdt2212, which had been placed on pylorus for pyloric stenosis around april, was found being fractured", it is assumed that the stent was fractured due to the patient lesion's peristalses and pressure and so on.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: stent fracture" this suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.
 
Event Description
On 30th june, distributor received the information that dxdt2212, which had been placed on pylorus for pyloric stenosis around april, was found being fractured and the fractured part was in stomach.After that, the fractured part was removed by using an over tube, and another stent was additionally placed.There were no patient complications as a result of this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NITI-S PYLORIC & DUODENAL UNCOVERED STENT
Type of Device
PYLORIC & DUODENAL STENT
Manufacturer (Section D)
TAEWOONG MEDICAL CO.,LTD.
14, gojeong-ro
wolgot-myeon
gimpo-si, 10022
KS  10022
Manufacturer (Section G)
TAEWOONG MEDICAL CO.,LTD.
14, gojeong-ro
wolgot-myeon
gimpo-si, 10022
KS   10022
Manufacturer Contact
lee
14, gojeong-ro
wolgot-myeon
gimpo-si, 10022
MDR Report Key10336751
MDR Text Key203668620
Report Number3003902943-2020-00068
Device Sequence Number1
Product Code MUM
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDXDT2212
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/08/2020
Initial Date FDA Received07/29/2020
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 Initial
Patient Sequence Number1
-
-