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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INCORPORATED ACUSNARE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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COOK INCORPORATED ACUSNARE UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number G22649
Device Problems Mechanical Problem (1384); Defective Device (2588); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2018
Event Type  malfunction  
Event Description
While performing a "colonscopy", the gi physician had full view of the raised polyp and attempted to open the duck bill snare to cauterize the polyp, and the snare would not open, would not close, and was unable to be visualized via the endoscopic camera. Much maneuvering by the tech in attempt to see the snare without effect, and the physician had to abort the polyp retrieval, pull the camera back and use a decent amount of force to pull the defective snare out. The tech and md stated it felt as if there were a kink preventing the snare from moving forward or back. Could not visualize any defect, but opened and used a new snare with good results.
 
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Brand NameACUSNARE
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
COOK INCORPORATED
wilson-cook medical, inc.
4900 bethania station rd
winston-salem NC 27105
MDR Report Key8114645
MDR Text Key128732918
Report Number8114645
Device Sequence Number0
Product Code KNS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/21/2018,11/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG22649
Device Catalogue NumberASDB-25-015-S
Device Lot NumberW4099969
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2018
Event Location Hospital
Date Report to Manufacturer11/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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