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

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.

• Brand Name: ACUSNARE
• Type of Device: UNIT, 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 Key: 8114645
• MDR Text Key: 128732918
• Report Number: 8114645
• Device Sequence Number: 0
• Product Code: KNS
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G22649
• Device Catalogue Number: ASDB-25-015-S
• Device Lot Number: W4099969
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 19710 DA