MAUDE Adverse Event Report: COOK IRELAND LTD CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE

Catalog Number CST-10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/06/2005

Event Type  Injury  

Manufacturer Narrative

Procode: kns unit, electrosurgical, endoscopic.

Event Description

Per journal article "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.

• Brand Name: CYSTOTOME CYSTOENTEROSTOMY NEEDLE KNIFE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10478225
• MDR Text Key: 205281505
• Report Number: 3005580113-2020-00404
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CST-10
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/07/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR