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

MAUDE Adverse Event Report: COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC

  • 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
 

COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE KNS UNIT, ELECTROSURGICAL, ENDOSCOPIC Back to Search Results
Catalog Number CST-10
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/06/2005
Event Type  Injury  
Manufacturer Narrative

Investigation is still pending. A follow up mdr will be submitted to include the investigation conclusions.

 
Event Description

"kahaleh et al. 2006 ¿endoscopic ultrasound drainage of pancreatic pseudocyst: a prospective comparison with conventional endoscopic drainage¿. Endoscopic management of pseudocysts by a conventional transenteric technique, i. E. Conventional transmural drainage (ctd), or by endoscopic ultrasound-guided drainage (eud), is well described. Our aim was to prospectively compare the short-term and long-term results of ctd and eud in the management of pseudocysts. A total of 99 consecutive patients underwent endoscopic management of pancreatic pseudocysts according to this predetermined treatment algorithm: patients with bulging lesions without obvious portal hypertension underwent ctd; all remaining patients underwent eud. 46 patients (37 men) underwent eud and 53 patients (39 men) had ctd. All ctd cystoenterostomy fistulas were created using a 10-fr cystoenterostome (wilson-cook medical and endo-flex instrumente, voerde, germany) [15]. Following access to the pseudocyst, one or two 10-fr double-pigtail endoprostheses were placed. Bleeding was defined as any hemorrhagic event occurring during or after the procedure that required any intervention or blood transfusion. One patient developed bleeding of the cystoenterostomy site that responded to balloon tamponade. This file was created to capture the bleeding of the cystoenterostomy site, as per clinical input received this would be related to cst-10 device.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
Type of DeviceKNS UNIT, ELECTROSURGICAL, ENDOSCOPIC
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer (Section G)
COOK IRELAND LTD
o halloran road
national technology park
limerick
Manufacturer Contact
heather ryan
o halloran road
national technology park
limerick 
MDR Report Key10490863
MDR Text Key211017367
Report Number3001845648-2020-00550
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK022595
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 08/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCST-10
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/07/2020
Event Location Hospital
Date Manufacturer Received08/07/2020
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 TREATMENT DATA
Date Received: 09/03/2020 Patient Sequence Number: 1
-
-